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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/NCT02985879
Registration number
NCT02985879
Ethics application status
Date submitted
1/12/2016
Date registered
7/12/2016
Date last updated
3/02/2021
Titles & IDs
Public title
A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
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Secondary ID [1]
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2016-001635-12
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Secondary ID [2]
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M15-562
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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:
Progressive Supranuclear Palsy
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Condition category
Condition code
Neurological
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Neurodegenerative diseases
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - ABBV-8E12
Placebo Comparator: Placebo - 0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks
Experimental: ABBV-8E12 2000 mg - Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
Experimental: ABBV-8E12 4000 mg - Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
Treatment: Drugs: Placebo
Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.
Treatment: Drugs: ABBV-8E12
Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.
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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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Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score
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Assessment method [1]
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The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive changes in score indicate worsening from baseline.
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Timepoint [1]
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Baseline, Week 52
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Primary outcome [2]
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Number of Participants With Adverse Events
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Assessment method [2]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section.
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Timepoint [2]
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From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks
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Secondary outcome [1]
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Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
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Assessment method [1]
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The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive changes in score indicate worsening from baseline.
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Timepoint [1]
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Baseline, Week 52
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Secondary outcome [2]
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Clinical Global Impression of Change (CGI-C) Score at Week 52
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Assessment method [2]
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The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
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Assessment method [3]
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Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume.
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Timepoint [3]
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Baseline, Week 52
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Secondary outcome [4]
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Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)
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Assessment method [4]
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The Schwab and England Activities of Daily Living (SEADL) consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.
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Timepoint [4]
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Baseline, Week 52
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Secondary outcome [5]
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Maximum Observed Serum Concentration (Cmax) for ABBV-8E12
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Assessment method [5]
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The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.
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Timepoint [5]
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First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
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Secondary outcome [6]
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Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12
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Assessment method [6]
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The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1.
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Timepoint [6]
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First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
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Secondary outcome [7]
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Area Under the Concentration Time Curve (AUC) for ABBV-8E12
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Assessment method [7]
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The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1.
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Timepoint [7]
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First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
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Secondary outcome [8]
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Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)
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Assessment method [8]
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The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1.
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Timepoint [8]
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First day of the Fifth Dosing Interval, Day 85
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Secondary outcome [9]
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Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score
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Assessment method [9]
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The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive changes in score indicate worsening from baseline.
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Timepoint [9]
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Baseline, Week 52
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Secondary outcome [10]
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Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score
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Assessment method [10]
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The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life.
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Timepoint [10]
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Baseline, Week 52
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Secondary outcome [11]
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Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score
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Assessment method [11]
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The Progressive Supranuclear Palsy Rating Scale (PSPRS) consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive changes in score indicate worsening from baseline.
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Timepoint [11]
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Baseline, Week 52
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Secondary outcome [12]
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Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
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Assessment method [12]
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Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify third ventricle atrophy. Positive changes in values indicate an increase in volume.
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Timepoint [12]
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Baseline, Week 52
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Secondary outcome [13]
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Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
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Assessment method [13]
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Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify Superior cerebellar peduncle atrophy. Negative changes in values indicate a reduction in volume.
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Timepoint [13]
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Baseline, Week 52
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Secondary outcome [14]
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Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
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Assessment method [14]
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Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify brainstem atrophy. Negative changes in values indicate a reduction in volume.
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Timepoint [14]
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Baseline, Week 52
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Secondary outcome [15]
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Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
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Assessment method [15]
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Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify whole brain atrophy. Negative changes in values indicate a reduction in volume.
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Timepoint [15]
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Baseline, Week 52
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Secondary outcome [16]
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Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
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Assessment method [16]
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Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify frontal lobe atrophy. Positive changes in values indicate an increase in volume.
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Timepoint [16]
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Baseline, Week 52
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Secondary outcome [17]
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Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26
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Assessment method [17]
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The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).
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Timepoint [17]
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From Baseline to Week 52
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Eligibility
Key inclusion criteria
Key
- Male or female participant with age 40 years or greater at the time of signed consent
- Meets the criteria for possible or probable progressive supranuclear palsy (PSP;
Steele-Richardson-Olszewski Syndrome)
- Presence of PSP symptoms for less than 5 years
- Participant is able to walk 5 steps with minimal assistance (stabilization of one arm
or use of cane/walker)
- Participant has an identified, reliable, study partner (e.g., caregiver, family
member, social worker, or friend)
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Minimum age
40
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
- Participants who weigh less than 44 kg (97 lbs) at screening
- Mini-Mental State Examination (MMSE) score less than 15 at screening
- Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
- Participant resides at a skilled nursing or dementia care facility, or admission to
such a facility is planned during the study period
- Evidence of any clinically significant neurological disorder other than PSP
- The participant has a history of or currently has schizophrenia, schizoaffective
disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental
Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10)
criteria
- Participant has had a significant illness or infection requiring medical intervention
in the past 30 days
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
12/12/2016
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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
20/11/2019
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Sample size
Target
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Accrual to date
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Final
378
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Westmead Hospital /ID# 154403 - Westmead
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Recruitment hospital [2]
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Q-Pharm Pty Limited /ID# 154410 - Herston
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Recruitment hospital [3]
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Royal Adelaide Hospital /ID# 153157 - Adelaide
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Recruitment hospital [4]
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Alfred Hospital /ID# 153158 - Melbourne
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Recruitment hospital [5]
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Neurodegenerative Disorders Re /ID# 153770 - West Perth
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4006 - Herston
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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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6005 - West Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Minnesota
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United States of America
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Missouri
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Nevada
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New Jersey
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New York
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Ohio
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Oregon
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Tennessee
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Texas
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Haute-Garonne
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France
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Provence-Alpes-Cote-d Azur
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France
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Bordeaux
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France
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Lille
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France
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Paris
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France
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Strasbourg
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Thueringen
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Germany
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Hausham
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Germany
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Munich
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Italy
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Calabria
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Italy
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Lazio
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Italy
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Milano
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Italy
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Milan
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Italy
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Pozzilli
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Italy
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Terni
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Italy
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Venezia LIDO
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Japan
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Aichi
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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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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Tokyo
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Spain
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Madrid
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Spain
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State/province [49]
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Sevilla
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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 efficacy, safety, tolerability, and pharmacokinetics
of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02985879
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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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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02985879
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