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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/NCT02945046
Registration number
NCT02945046
Ethics application status
Date submitted
25/10/2016
Date registered
26/10/2016
Date last updated
9/11/2021
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)
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Scientific title
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 Versus Placebo for the Prevention of Epidosic Cluster Headache
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Secondary ID [1]
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2016-003278-42
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Secondary ID [2]
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TV48125-CNS-30056
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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:
Episodic 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
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Participants will receive placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Experimental: Fremanezumab 675 mg/Placebo/Placebo - Participants will receive placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 milligrams (mg) administered as 3 subcutaneous injections (225 mg/1.5 milliliters [mL]) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Experimental: Fremanezumab 900/225/225 mg - Participants will receive fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Treatment: Drugs: Fremanezumab
Fremanezumab will be administered per dose and schedule specified in the arm.
Treatment: Drugs: Placebo
Placebo matching to fremanezumab will be administered per schedule specified in the arm.
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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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Mean Change From Baseline in the Weekly Average Number of Cluster Headache (CH) Attacks During the 4-Week Period After Administration of the First Dose of the IMP
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Assessment method [1]
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A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. Least Squares (LS) mean calculated using analysis of covariance (ANCOVA) model with baseline preventive medication use (yes or no), sex, region (United States [US]/Canada or other), and treatment as fixed effects and the baseline number of CH attacks as a covariate. Change from baseline in the overall weekly average number of CH attacks during the 4-week period after administration of the first dose of study drug (based on Week 0 to 4 data) is reported.
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Timepoint [1]
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Baseline (Week 0), up to Week 4
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Secondary outcome [1]
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Percentage of Participants With a =50% Reduction From Baseline in the Weekly Average Number of CH Attacks During the 4-Week Period After the First Dose of the IMP
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Assessment method [1]
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A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation.
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Timepoint [1]
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Baseline (Week 0), up to Week 4
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Secondary outcome [2]
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Mean Change From Baseline in Weekly Average Number of CH Attacks During the 12-Week Period After Administration of the First Dose of the IMP
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Assessment method [2]
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A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. LS mean calculated using mixed model for repeated measures (MMRM) with baseline preventive medication use (yes or no), gender, region (US/Canada or other), treatment, month, and month-by-treatment interaction as fixed effects and baseline number of CH attacks as a covariate. Change from baseline in the overall weekly average number of CH attacks during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported.
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Timepoint [2]
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Baseline (Week 0), up to Week 12
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Secondary outcome [3]
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Mean Change From Baseline in Weekly Average Number of CH Attacks During the 4-Week Period After Administration of the Third Dose of the IMP
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Assessment method [3]
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A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. LS mean calculated using MMRM with baseline preventive medication use (yes or no), gender, region (US/Canada or other), treatment, month, and month-by-treatment interaction as fixed effects and baseline number of CH attacks as a covariate. Change from baseline in the overall weekly average number of CH attacks during the 4-week period after administration of the first dose of study drug (based on Week 8 to 12 data) is reported.
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Timepoint [3]
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Baseline (Week 0), Week 8 up to Week 12
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Secondary outcome [4]
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Mean Change From Baseline in the Weekly Average Number of Days With Use of Cluster-Specific Acute Headache Medications (Triptans and Ergot Compounds) During the 12-Week Period After the First Dose of the IMP
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Assessment method [4]
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A maximum of 2 concomitant preventive medications for CH were allowed during the study. Participants must have been on a stable dose and regimen of the concomitant medication for at least 2 weeks before screening and throughout the study. LS mean calculated using ANCOVA model with baseline preventive medication use (yes or no), gender, region (US/Canada or other), and treatment as fixed effects and the baseline number of cluster headache attacks as a covariate. Baseline data and the mean change from baseline in the overall weekly average number of days with the use of cluster-specific acute headache medications (triptans and ergot compounds) during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported.
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Timepoint [4]
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Baseline (Week 0), up to Week 12
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Secondary outcome [5]
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Mean Change From Baseline in the Weekly Average Number of Days Oxygen Was Used to Treat Episodic Cluster Headache (ECH) During the 12-Week Period After the First Dose of the IMP
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Assessment method [5]
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LS mean calculated using ANCOVA model with baseline preventive medication use (yes or no), gender, region (US/Canada or other), and treatment as fixed effects and the baseline number of cluster headache attacks as a covariate. Baseline data and the mean change from baseline in the overall weekly average number of days oxygen was used to treat ECH during the 12-week period after administration of the first dose of IMP (based on Week 0 to 12 data) is reported.
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Timepoint [5]
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Baseline (Week 0), up to Week 12
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Secondary outcome [6]
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Number of Participants Who Perceived Improvement of CH-Associated Pain From Baseline as Measured by the Patient-Perceived Satisfactory Improvement (PPSI) Scale at Weeks 1, 4, 8, and 12
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Assessment method [6]
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The PPSI assessment was developed to measure pain intensity and was adjusted for CH symptoms improvement. Participants marked the level of CH-associated pain and indicated if pain is "1=much worse," "2=moderately worse," "3=slightly worse," "4=unchanged," "5=slightly improved," "6=moderately improved," or "7=much improved" compared with 4 weeks prior. PPSI was defined as the change in pain that corresponds with a minimal rating of "5=slightly improved." Data at Week 1 was recorded on Day 7 in the electronic diary device at home. Week 12 data also included assessment at the early withdrawal visit for participants who discontinued the study early.
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Timepoint [6]
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Baseline, Weeks 1, 4, 8, and 12
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Secondary outcome [7]
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Number of Participants With Adverse Events (AEs)
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline up to Week 12
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Secondary outcome [8]
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Number of Participants With Potentially Clinically Significant Laboratory (Serum Chemistry, Hematology, and Urinalysis) Abnormal Results
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Assessment method [8]
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Serum chemistry, hematology, urinalysis laboratory tests with potentially clinically significant abnormal findings included: alanine aminotransferase (ALP), 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); Blood Urea Nitrogen =10.71 millimoles (mmol)/L; creatinine =177 umol/L; hemoglobin less than or equal to (=)115 grams (g)/L (males) or =95 g/L (females); leukocytes =20*10^9/L or =3*10^9/L; eosinophils =10%; hematocrit <0.37 L/L (males) and <0.32 L/L (females); platelets =700*10^9/L or =75*10^9/L; 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.
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Timepoint [8]
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Baseline up to Week 12
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Secondary outcome [9]
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Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline up to Week 12
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Secondary outcome [10]
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Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
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Assessment method [10]
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Potentially clinically significant abnormal vital signs findings included: pulse rate =120 beats per minute (bpm) and increase of 15 bpm; systolic blood pressure =90 millimeters of mercury (mmHg) and decrease of 20 mmHg; diastolic blood pressure =50 mmHg and decrease of 15 mmHg, or =105 mmHg and increase of 15 mmHg. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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Timepoint [10]
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Baseline up to Week 12
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Secondary outcome [11]
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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 [11]
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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.
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Timepoint [11]
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Baseline up to Week 12
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Secondary outcome [12]
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Number of Participants Who Received Concomitant Medications
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Assessment method [12]
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Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, 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 etc.
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Timepoint [12]
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Baseline up to Week 12
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Secondary outcome [13]
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Number of Participants With Injection Site Reactions
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Assessment method [13]
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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, swelling, and pruritus. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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Timepoint [13]
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Baseline up to Week 12
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Secondary outcome [14]
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Number of Participants With Hypersensitivity/Anaphylaxis Reactions
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Assessment method [14]
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A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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Timepoint [14]
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Baseline up to Week 12
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Secondary outcome [15]
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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 [15]
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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.
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Timepoint [15]
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Baseline up to Week 12
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Eligibility
Key inclusion criteria
- The participant has a history of ECH according to the International Classification of
Headache Disorders - 3 beta criteria (Headache Classification Committee of the
International Headache Society [IHS] 2013) for =12 months prior to screening.
- The participant has a total body weight of =45 kg (99 lbs.)
- The participant is in good health in the opinion of the investigator
- Women of childbearing potential (WOCBP) whose male partners are potentially fertile
(that is, no vasectomy) must use highly effective birth control methods for the
duration of the study.
- Men must be sterile, or if they are potentially fertile/reproductively competent (not
surgically [for example, vasectomy] or congenitally sterile) and their female partners
are of childbearing potential, must agree to use, together with their female partners,
acceptable birth control for the duration of the study.
- If a participant is receiving Botox, it should be in a stable dose regimen, considered
as having =2 cycles of Botox prior to screening. The participant should not receive
Botox during the run-in period up to the evaluation period (4 weeks) where the primary
endpoint is evaluated.
- 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
- The participant has used systemic steroids for any medical reason (including treatment
of the current CH cycle within =7 days prior to screening The participant has used an
intervention/device (for example, scheduled nerve blocks) for headache during the 4
weeks prior to screening.
- The participant has clinically significant hematological, renal, endocrine,
immunologic, pulmonary, gastrointestinal, genitourinary, cardiovascular, neurologic,
hepatic, or ocular disease at the discretion of the investigator.
- The participant has evidence or medical history of clinically significant psychiatric
issues determined at the discretion of the investigator.
- The participant has a past or current history of cancer or malignant tumor in the past
5 years, except for appropriately treated non-melanoma skin carcinoma.
- The participant is pregnant or lactating.
- The participant has a history of hypersensitivity reactions to injected proteins,
including monoclonal antibodies.
- The participant has participated in a clinical study of a monoclonal antibody within 3
months or 5 half-lives before administration of the first dose of the IMP, whichever
is longer, unless it is known that the participant received placebo during the study.
- The participant has a history of prior exposure to a monoclonal antibody targeting the
calcitonin gene-related peptide (CGRP) pathway (AMG 334, ALD304, LY2951742, or
fremanezumab). If participant has participated in a clinical study with any of these
monoclonal antibodies, it has to be confirmed that the participant received placebo in
order to be eligible for this study.
- The participant is an employee of the sponsor/participating study center who is
directly involved in the study or is the relative of such an employee.
- The participant has an active implant for neurostimulation used in the treatment of
CH.
- The participant is a member of a vulnerable population (for example, people kept in
detention).
- The participant has a history of alcohol abuse prior to screening and/or drug abuse
that in the investigator's opinion could interfere with the study evaluations or the
participant's safety .
- 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
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
19/01/2017
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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
13/05/2019
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Sample size
Target
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Accrual to date
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Final
169
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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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United States of America
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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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Michigan
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Nevada
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New Hampshire
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New Jersey
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0
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New Mexico
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0
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New York
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Virginia
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Canada
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Calgary
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Canada
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Toronto
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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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0
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Germany
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Konigstein im Taunus
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0
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Germany
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Rostock
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0
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Israel
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Ashkelon
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Israel
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0
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Hadera
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0
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Israel
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0
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Holon
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0
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Israel
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Jerusalem
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0
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Israel
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Netanya
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0
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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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0
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Italy
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Modena
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0
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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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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Netherlands
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Zwolle
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Poland
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Bialystok
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Poland
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Krakow
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Poland
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Lodz
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Poland
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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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State/province [61]
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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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Summary
Brief summary
This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled,
parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125
(Fremanezumab) versus placebo in adult participants for the prevention of ECH.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02945046
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Contacts
Principal investigator
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Teva Medical Expert, MD
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Address
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Teva Branded Pharmaceutical Products R&D, Inc.
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02945046
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