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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/NCT02964338
Registration number
NCT02964338
Ethics application status
Date submitted
11/11/2016
Date registered
16/11/2016
Date last updated
9/11/2021
Titles & IDs
Public title
A Study Comparing the Efficacy and Safety of Fremanezumab (TEV-48125) for the Prevention of Chronic Cluster Headache (CCH)
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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 Chronic Cluster Headache
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Secondary ID [1]
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2016-003171-21
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Secondary ID [2]
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TV48125-CNS-30057
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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:
Chronic 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 received placebo via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injections at Weeks 4 and 8.
Experimental: Fremanezumab 675/225/225 mg - Participants received placebo via an approximately 1-hour intravenous infusion and fremanezumab at 675 milligrams (mg) as 3 subcutaneous injections (225 mg/1.5 milliliters [mL]) at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
Experimental: Fremanezumab 900/225/225 mg - Participants received fremanezumab at 900 mg via an approximately 1-hour intravenous infusion and placebo administered as 3 subcutaneous injections at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
Treatment: Drugs: Fremanezumab
Fremanezumab will be administered as per the dose and schedule specified in the respective arms.
Treatment: Drugs: Placebo
Placebo matching to fremanezumab will be administered as per the schedule specified in the respective arms.
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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 Overall Monthly Average Number of CH Attacks Up to Week 12
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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 monthly 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 [1]
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Baseline Period (from at least Week -4 to Week 0), Up to Week 12
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Secondary outcome [1]
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Percentage of Participants With a =50% Reduction From Baseline in the Monthly Average Number of CH Attacks Up to Week 12
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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 Period (from at least Week -4 to Week 0) up to Week 12
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Secondary outcome [2]
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Mean Change From Baseline in the Monthly Average Number of CH Attacks at Week 4 and Week 12
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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) =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. Mean change from baseline in monthly average number of CH attacks during 4-week period after administration of first dose of study drug (based on Week 0 to 4 data) and during 4-week period after administration of third dose of study drug (based on Week 8 to 12 data) is reported.
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Timepoint [2]
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Baseline Period (from at least Week -4 to Week 0), Week 4 and Week 12
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Secondary outcome [3]
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Mean Change From Baseline in the Overall Weekly Average Number of Days With Use of Cluster-Specific Acute Headache Medications (Triptans and Ergot Compounds) Up to Week 12
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Assessment method [3]
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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. 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 [3]
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Baseline Period (from at least Week -4 to Week 0), 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 Oxygen Was Used to Treat CCH Up to Week 12
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Assessment method [4]
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Baseline data and the mean change from baseline in the overall weekly average number of days oxygen was used to treat CCH 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 Period (from at least Week -4 to Week 0), Up to Week 12
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Secondary outcome [5]
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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 [5]
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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 [5]
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Baseline and Weeks 1, 4, 8, and 12
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Secondary outcome [6]
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Number of Participants With Adverse Events (AEs)
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Assessment method [6]
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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. Severity was rated by the Investigator on a scale of mild, moderate and severe, with severe as an AE that prevents usual activities. 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 [6]
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Baseline up to Week 12
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Secondary outcome [7]
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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 [7]
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Serum chemistry, hematology, urinalysis laboratory tests with potentially clinically significant abnormal findings included: Alanine Aminotransferase (units/liter [U/L]) =3*upper limit of normal (ULN); Aspartate Aminotransferase (U/L) =3*ULN; Bilirubin (Total) =34.2 micromole/liter (umol/L); Blood Urea Nitrogen =10.71 millimole (mmol)/L; Creatinine =177 umol/L; Gamma Glutamyl Transferase (U/L) =3*ULN; hemoglobin less than (<)115 grams (g)/L (males) or less than or equal to (=)95 g/L (females); leukocytes =20*10^9/L or =3*10^9/L; Eosinophils/Leukocytes =10%; Hematocrit <0.37 L/L (males) and <0.32 L/L (females); platelets =700*10^9/L or =75*10^9/L; blood =2 unit increase from baseline; urine glucose (milligrams/decilitre [mg/dL]) =2 U increase from baseline; ketones (mg/dL) =2 U increase from baseline; urine protein (mg/dL) =2 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 [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 Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
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Assessment method [8]
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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 [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 Potentially Clinically Significant Abnormal Vital Signs Values
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Assessment method [9]
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Potentially clinically significant abnormal vital signs findings included: pulse rate =50 beats/minute (bpm) and decrease of =15 bpm, or =120 bpm and increase of =15 bpm; systolic blood pressure =90 millimeters of mercury (mmHg) and decrease of =20 mmHg, or =180 mmHg and increase of =20 mmHg; diastolic blood pressure =50 mmHg and decrease of =15 mmHg, or =105 mmHg and increase of =15 mmHg; respiratory rate <10 breaths/minute; and body temperature =38.3 degrees centigrade and change of =1.1 degrees centigrade. 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 Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters
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Assessment method [10]
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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 [10]
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Baseline to Week 12
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Secondary outcome [11]
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Number of Participants With Injection Site Reactions
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Assessment method [11]
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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, hypersensitivity, swelling, rash, and flushing. 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 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.
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Timepoint [12]
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Baseline up to Week 12
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Eligibility
Key inclusion criteria
- The participant has a history of CCH according to the International Classification of
Headache Disorders - 3 beta criteria (Headache Classification Committee of the
International Headache Society [IHS] 2013) for greater than or equal to (=)12 months
prior to screening.
- The participant has a total body weight of =45 kilograms (kg) (99 pounds [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.
- If a participant is receiving Botox, it should be in a stable dose regimen, which is
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 (12 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 cluster headache (CH) cycle within less than or equal to (=)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 investigational
medicinal product (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
17/01/2017
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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
18/07/2018
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Sample size
Target
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Accrual to date
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Final
259
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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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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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Arizona
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Connecticut
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Toronto
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Finland
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Helsinki
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Oulu
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Turku
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Berlin
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Kiel
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Konigstein im Taunus
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Rostock
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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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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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Modena
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Italy
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Zwolle
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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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Sweden
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Huddinge
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Country [58]
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Sweden
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State/province [58]
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Vallingby
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Country [59]
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United Kingdom
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State/province [59]
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Glasgow
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Country [60]
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United Kingdom
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London
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Country [61]
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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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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the current study is to evaluate the efficacy and safety of Fremanezumab
(TEV-48125), in the prevention of CCH in adult participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02964338
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Teva Medical Expert, MD
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Teva Branded Pharmaceutical Products R&D, Inc.
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02964338
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