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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03107052
Registration number
NCT03107052
Ethics application status
Date submitted
23/03/2017
Date registered
11/04/2017
Titles & IDs
Public title
A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache
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Scientific title
A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache
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Secondary ID [1]
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2016-003172-43
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Secondary ID [2]
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TV48125-CNS-30058
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Universal Trial Number (UTN)
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Trial acronym
ENFORCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cluster Headache
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Condition category
Condition code
Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fremanezumab
Experimental: Fremanezumab 225 mg Monthly - Participants with ECH or CCH who received fremanezumab at 900 mg intravenous (IV) infusion at Week 0 and fremanezumab at 225 mg subcutaneous (SC) injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056 or TV48125-CNS-30057, and participants with CCH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; will receive fremanezumab at 225 mg SC injection monthly (approximately every 4 weeks, administered as single SC injection of fremanezumab at 225 mg \[225 mg/1.5 milliliter {mL}\] at Week 0 and 36; and 2 placebo SC injections at Weeks 0, 12, 24, and 36 for blinding in participants rolled over from Study TV48125-CNS-30056; fremanezumab at 225 mg as a single SC injection (225 mg/1.5 mL) at Week 0, 12, 24, and 36; 2 SC injections of placebo at Week 0 for blinding in participants rolled over from Study TV48125-CNS-30057) through Week 36 in this study.
Experimental: Fremanezumab 675/225 mg Monthly - Participants with CCH who received placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; will receive fremanezumab 675 mg SC injection as loading dose (administered as 3 SC injections of fremanezumab at 225 mg \[225 mg/1.5 mL\] at Week 0) followed by monthly (approximately every 4 weeks) fremanezumab at 225 mg SC injection (administered as single SC injection of fremanezumab at 225 mg \[225 mg/1.5 mL\] at Weeks 12, 24, and 36) through Week 36.
Experimental: Fremanezumab 675 mg Quarterly - Participants with ECH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study; or placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056; will receive fremanezumab at 675 mg SC injection quarterly (approximately every 12 weeks, administered as 3 SC injections of fremanezumab at 225 mg \[225 mg/1.5 mL\] at Weeks 0 an 36; and single placebo SC injections at Weeks 4, 8, 16, 20, 28, and 32 for blinding) through Week 36.
Treatment: Drugs: Fremanezumab
Fremanezumab
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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 (AEs)
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Assessment method [1]
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An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [1]
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Baseline up to follow-up (Week 68)
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Primary outcome [2]
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Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Serum Chemistry
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Assessment method [2]
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Serum chemistry tests with potentially clinically significant abnormal findings included: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH) each =3\*upper limit of normal (ULN); Blood urea nitrogen (BUN) =10.71 millimole (mmol)/L; Bilirubin (Total) =34.2 micromole/liter (umol/L); and Creatinine =177 umol/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [2]
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Baseline up to end of treatment (Week 40)
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Primary outcome [3]
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Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Hematology
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Assessment method [3]
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Hematology tests with potentially clinically significant abnormal findings included: hemoglobin less than or equal to (=)115 grams (g)/L (males) or =95 g/L (females), leukocytes count =20\*10\^9/L or =3\*10\^9/L, eosinophils =10%, hematocrit \<0.37 L/L (males) and \<0.32 L/L (females), platelets count =700\*10\^9/L or =75\*10\^9/L, absolute neutrophil count (ANC) =1\*10\^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [3]
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Baseline up to end of treatment (Week 40)
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Primary outcome [4]
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Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Urinalysis
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Assessment method [4]
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Urinalysis laboratory tests with potentially clinically significant abnormal findings included: haemoglobin, urine glucose, ketones, urine total protein each =2 unit (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [4]
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Baseline up to end of treatment (Week 40)
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Primary outcome [5]
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Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Coagulation Laboratory Test Results
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Assessment method [5]
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Coagulation parameters included: prothrombin time (PT) (seconds) and prothrombin international normalized ratio (INR). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). Missing PT and prothrombin INR shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [5]
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Baseline up to end of treatment (Week 40)
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Primary outcome [6]
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Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
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Assessment method [6]
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Potentially clinically significant abnormal vital signs findings included: Pulse rate =120 beats per minute (bpm) and increase from baseline of =15 bpm, or =50 bpm and decrease from baseline of =15 bpm; Systolic blood pressure =90 millimeters of mercury (mmHg) and decrease from baseline of =20 mmHg, or =180 mmHg and increase from baseline of =20 mmHg; Diastolic blood pressure =50 mmHg and decrease from baseline of =15 mmHg, or =105 mmHg and increase from baseline of =15 mmHg; Temperature \>38.3 degrees celsius (°C). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [6]
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Baseline up to follow-up (Week 68)
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Primary outcome [7]
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Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters
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Assessment method [7]
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ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. Missing ECG shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [7]
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Baseline up to follow-up (Week 68)
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Primary outcome [8]
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Number of Participants With Abnormal Physical Examination Findings
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Assessment method [8]
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A complete physical examination included the following organ systems: general appearance; head, eyes, ears, nose, and throat; chest and lungs; heart; abdomen; musculoskeletal; skin; lymph nodes; and neurological. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [8]
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Baseline up to follow-up (Week 68)
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Primary outcome [9]
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Number of Participants With Injection Site Reactions
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Assessment method [9]
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Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from Medical Dictionary for Regulatory Activities (MedDRA) version 18.1 were offered without a threshold applied. Injection site reactions included injection site erythema, induration, pain, haemorrhage, bruising, rash, warmth, and pruritus. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [9]
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Baseline up to Week 36
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Primary outcome [10]
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Number of Participants With Hypersensitivity/Anaphylaxis Reactions
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Assessment method [10]
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A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [10]
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Baseline up to Week 36
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Primary outcome [11]
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Number of Participants Who Received Concomitant Medications
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Assessment method [11]
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Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (homeopathic), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes. Baseline refers to values from the pivotal studies.
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Timepoint [11]
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Baseline up to follow-up (Week 68)
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Primary outcome [12]
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Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
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Assessment method [12]
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eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent. Baseline refers to the baseline values from the pivotal studies.
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Timepoint [12]
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Baseline up to follow-up (Week 68)
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Eligibility
Key inclusion criteria
* The participant completes either the Phase 3 pivotal study for ECH (Study TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057) without important protocol deviations related to participant safety and participant compliance.
* Prior to 15 June 2018, participants from the ECH study and the CCH study were enrolled. After 15 June 2018, only participants who participated in the ECH study (Study TV48125-CNS-30056) will be enrolled for active treatment.
* In addition, participants who do not complete the pivotal efficacy studies, and participants who complete the pivotal efficacy studies but will not continue treatment during this long-term safety study, will be offered to enroll in this study for the purpose of evaluating ADAs, and safety (adverse events and concomitant medications) approximately 7.5 months after administration of the last dose of the IMP.
* Additional criteria apply, please contact the investigator for more information
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Minimum age
18
Years
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Maximum age
70
Years
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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
* Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation)
* Additional criteria apply, please contact the investigator for more information
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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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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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
27/04/2017
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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
11/06/2019
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Sample size
Target
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Accrual to date
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Final
275
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Teva Investigational Site 78120 - Auchenflower
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Recruitment hospital [2]
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Teva Investigational Site 78118 - Clayton
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Recruitment hospital [3]
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Teva Investigational Site 78123 - Melbourne
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Recruitment hospital [4]
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Teva Investigational Site 78122 - Parkville
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Recruitment hospital [5]
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Teva Investigational Site 78121 - Randwick
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Recruitment postcode(s) [1]
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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3050 - Parkville
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Recruitment postcode(s) [5]
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2031 - Randwick
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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North Carolina
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Ohio
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Ontario
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Canada
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Calgary
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Finland
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Helsinki
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Finland
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Oulu
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Finland
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Turku
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Konigstein im Taunus
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Germany
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Rostock
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Israel
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Ashkelon
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Israel
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Hadera
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Netanya
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Tel-Aviv
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Italy
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Milan
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Italy
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Modena
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Rome
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Leiden
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Nijmegen
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Zwolle
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Poland
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Bialystok
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Krakow
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Lodz
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Szczecin
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Spain
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Galdakao.
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valladolid
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Spain
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Zaragoza
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Sweden
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Huddinge
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Sweden
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Vallingby
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United Kingdom
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Glasgow
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Teva Branded Pharmaceutical Products R&D, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (CH). Participants who complete the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the current study will visit the investigational center for investigational medicinal product (IMP) administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (anti-drug antibodies \[ADAs\]), and biomarker analyses. Participants will return to the investigational center for a follow-up visit to evaluate ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant medications) approximately 7.5 months after the last dose of IMP.
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Trial website
https://clinicaltrials.gov/study/NCT03107052
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Teva Medical Expert, MD
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Address
0
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Teva Branded Pharmaceutical Products R&D, Inc.
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0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/52/NCT03107052/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/52/NCT03107052/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03107052