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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03781167
Registration number
NCT03781167
Ethics application status
Date submitted
18/12/2018
Date registered
19/12/2018
Date last updated
23/10/2023
Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
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Scientific title
A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease
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Secondary ID [1]
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2018-002144-85
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Secondary ID [2]
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M15-741
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease (PD)
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Condition category
Condition code
Neurological
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Parkinson's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-951
Experimental: ABBV-951 Low Dose Subgroup - After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
Experimental: ABBV-951 High Dose Subgroup - After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was = 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
Treatment: Drugs: ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events
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Assessment method [1]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
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Timepoint [1]
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From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
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Primary outcome [2]
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Number of Participants With Adverse Events of Special Interest
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Assessment method [2]
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Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.
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Timepoint [2]
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From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
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Primary outcome [3]
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Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale
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Assessment method [3]
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Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria > 2 or > C was recorded as an adverse event (AE).
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Timepoint [3]
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Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52
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Primary outcome [4]
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Hematocrit (Hematology): Change From Baseline to End of Study
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Assessment method [4]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [4]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [5]
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Hemoglobin (Hematology): Change From Baseline to End of Study
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Assessment method [5]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [5]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [6]
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Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
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Assessment method [6]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [6]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [7]
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White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
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Assessment method [7]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [7]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [8]
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Neutrophils (Hematology): Change From Baseline to End of Study
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Assessment method [8]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [8]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [9]
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Lymphocytes (Hematology): Change From Baseline to End of Study
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Assessment method [9]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [9]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [10]
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Monocytes (Hematology): Change From Baseline to End of Study
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Assessment method [10]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [10]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [11]
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Absolute Platelet Count (Hematology): Change From Baseline to End of Study
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Assessment method [11]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [11]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [12]
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Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
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Assessment method [12]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [12]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [13]
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Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
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Assessment method [13]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [13]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [14]
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Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
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Assessment method [14]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [14]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [15]
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Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
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Assessment method [15]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [15]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [16]
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Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [16]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [16]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [17]
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Creatinine (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [17]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [17]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [18]
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Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [18]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [18]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [19]
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Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [19]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [19]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [20]
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Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [20]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [20]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [21]
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Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [21]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [21]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [22]
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Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [22]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [22]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [23]
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Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [23]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [23]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [24]
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Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [24]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [24]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [25]
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Sodium (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [25]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [25]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [26]
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Potassium (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [26]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [26]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [27]
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Calcium (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [27]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [27]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [28]
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Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [28]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [28]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [29]
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Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [29]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [29]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [30]
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Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [30]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [30]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [31]
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Albumin (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [31]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [31]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [32]
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Glucose (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [32]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [32]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [33]
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Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [33]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [33]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [34]
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Magnesium (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [34]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [34]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [35]
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Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [35]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [35]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [36]
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Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [36]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [36]
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Baseline, Weeks 6, 26, and 52
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Primary outcome [37]
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Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [37]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [37]
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Baseline, Weeks 6, 26, and 52
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Primary outcome [38]
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Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
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Assessment method [38]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [38]
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Baseline, Weeks 6, 26, and 52
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Primary outcome [39]
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pH (Urinalysis): Change From Baseline to End of Study
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Assessment method [39]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [39]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [40]
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Specific Gravity (Urinalysis): Change From Baseline to End of Study
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Assessment method [40]
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Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
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Timepoint [40]
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Baseline, Weeks 6, 26, 39, and 52
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Primary outcome [41]
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Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
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Assessment method [41]
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Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
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Timepoint [41]
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Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
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Primary outcome [42]
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Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
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Assessment method [42]
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Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
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Timepoint [42]
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Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
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Primary outcome [43]
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Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
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Assessment method [43]
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Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
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Timepoint [43]
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Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
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Primary outcome [44]
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Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
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Assessment method [44]
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12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
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Timepoint [44]
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Baseline, Day 1 (postdose), Weeks 6 and 52
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Primary outcome [45]
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Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
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Assessment method [45]
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12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
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Timepoint [45]
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Baseline, Day 1 (postdose), Weeks 6 and 52
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Primary outcome [46]
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Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
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Assessment method [46]
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12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
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Timepoint [46]
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Baseline, Day 1 (postdose), Weeks 6 and 52
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Primary outcome [47]
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Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
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Assessment method [47]
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12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
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Timepoint [47]
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Baseline, Day 1 (postdose), Weeks 6 and 52
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Primary outcome [48]
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Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
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Assessment method [48]
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0
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
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Timepoint [48]
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Baseline, Day 1 (postdose), Weeks 6 and 52
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Primary outcome [49]
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Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
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Assessment method [49]
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0
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
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Timepoint [49]
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Baseline, Day 1 (postdose), Weeks 6 and 52
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Primary outcome [50]
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Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
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Assessment method [50]
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0
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
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Timepoint [50]
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Baseline, Day 1 (postdose), Weeks 6 and 52
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Secondary outcome [1]
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Average Daily Normalized "Off" Time: Change From Baseline to End of Study
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Assessment method [1]
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Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits.
"Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When "Off" was the first morning symptom upon awakening, this was considered morning akinesia in this study.
Baseline value is defined as the average of normalized "Off" time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
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Timepoint [1]
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Baseline, Weeks 1, 6, 13, 26, 39, and 52
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Secondary outcome [2]
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Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
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Assessment method [2]
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Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits.
"On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants.
Baseline value is defined as the average of normalized "On" time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
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Timepoint [2]
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Baseline, Weeks 1, 6, 13, 26, 39, and 52
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Secondary outcome [3]
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Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
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Assessment method [3]
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Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits.
"On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants.
Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement.
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Timepoint [3]
0
0
Baseline, Weeks 1, 6, 13, 26, 39, and 52
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Secondary outcome [4]
0
0
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
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Assessment method [4]
0
0
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
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Timepoint [4]
0
0
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
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Secondary outcome [5]
0
0
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
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Assessment method [5]
0
0
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
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Timepoint [5]
0
0
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
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Secondary outcome [6]
0
0
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
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Assessment method [6]
0
0
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
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Timepoint [6]
0
0
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
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Secondary outcome [7]
0
0
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
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Assessment method [7]
0
0
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part IV assesses the participant's motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
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Timepoint [7]
0
0
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
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Secondary outcome [8]
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0
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
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Assessment method [8]
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0
The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often] with the exception of Question 1 score ranging from 0 [very often] to 4 [never]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline.
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Timepoint [8]
0
0
Baseline, Weeks 6, 13, 26, 39, and 52
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Secondary outcome [9]
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0
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
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Assessment method [9]
0
0
The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline.
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Timepoint [9]
0
0
Baseline, Weeks 6, 13, 26, 39, and 52
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Secondary outcome [10]
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The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
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Assessment method [10]
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0
The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.
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Timepoint [10]
0
0
Baseline, Weeks 6, 13, 26, 39, and 52
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Eligibility
Key inclusion criteria
- Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is
levodopa-responsive
- Participants must be judged by the investigator to be inadequately controlled by
current therapy, have recognizable/identifiable "Off" and "On" states (motor
fluctuations), and have a minimum of 2.5 hours of "Off" time per day
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Minimum age
30
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant is cognitively impaired and is not able to safely and effectively manage
the drug delivery system and the diaries and is not able to adhere to the study
- Participant is considered by the investigator to be an unsuitable candidate to receive
ABBV-951 for any reason
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/04/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/08/2022
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Sample size
Target
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Accrual to date
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Final
244
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital /ID# 207628 - Concord
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Recruitment hospital [2]
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Westmead Hospital /ID# 207633 - Westmead
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Recruitment hospital [3]
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Royal Adelaide Hospital /ID# 207634 - Adelaide
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Recruitment hospital [4]
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Alfred Health /ID# 207632 - Melbourne
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Recruitment hospital [5]
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Perron Institute /ID# 207627 - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Florida
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Illinois
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Indiana
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Kansas
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Kentucky
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Massachusetts
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Belgium
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Vlaams-Brabant
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Belgium
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Brugge
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Belgium
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Liege
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Canada
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Denmark
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Hovedstaden
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Denmark
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Midtjylland
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Denmark
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Syddanmark
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Germany
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Baden-Wuerttemberg
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Germany
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Beelitz-Heilstaetten
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Germany
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Haag
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Italy
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Messina
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Italy
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Milan
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Italy
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Padova
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Japan
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Hokkaido
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Japan
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Kyoto
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Japan
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Osaka
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Japan
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Tokyo
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Netherlands
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Zuid-Holland
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Netherlands
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Nieuwegein
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Russian Federation
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Sankt-Peterburg
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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A Coruna
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Granada
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Spain
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Madrid
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Spain
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Sevilla
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Sweden
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Skane Lan
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Sweden
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Stockholms Lan
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Sweden
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Vastra Gotalands Lan
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United Kingdom
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Scotland
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United Kingdom
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London
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United Kingdom
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to assess the safety and tolerability of ABBV-951
(Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).
This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or
High Dose) based on the modal total daily dose (most frequent dose) over the treatment
period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03781167
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Fax
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03781167
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