Back to results

A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

Primary Purpose

Episodic Cluster Headache

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fremanezumab

Placebo

About this trial

This is an interventional treatment trial for Episodic Cluster Headache

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Fremanezumab 675 mg/Placebo/Placebo

Fremanezumab 900/225/225 mg

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

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

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

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.

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

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.

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

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.

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

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.

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

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.

Number of Participants With Adverse Events (AEs)

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.

Number of Participants With Potentially Clinically Significant Laboratory (Serum Chemistry, Hematology, and Urinalysis) Abnormal Results

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.

Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results

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.

Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

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.

Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters

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.

Number of Participants Who Received Concomitant Medications

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.

Number of Participants With Injection Site Reactions

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.

Number of Participants With Hypersensitivity/Anaphylaxis Reactions

A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)

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.

Full Information

NCT ID

NCT02945046

First Posted

October 25, 2016

Last Updated

November 6, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02945046

Brief Title

A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated as a result of a pre-specified futility analysis at the interim of 150 participants completing the efficacy analysis of the study.

Study Start Date

January 19, 2017 (Actual)

Primary Completion Date

May 13, 2019 (Actual)

Study Completion Date

May 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Episodic Cluster Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

169 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Fremanezumab 675 mg/Placebo/Placebo

Arm Type

Experimental

Arm Description

Arm Title

Fremanezumab 900/225/225 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fremanezumab

Other Intervention Name(s)

TEV-48125

Intervention Description

Fremanezumab will be administered per dose and schedule specified in the arm.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline (Week 0), up to Week 4

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline (Week 0), up to Week 4

Title

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

Description

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.

Time Frame

Baseline (Week 0), up to Week 12

Title

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

Description

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.

Time Frame

Baseline (Week 0), Week 8 up to Week 12

Title

Description

Time Frame

Baseline (Week 0), up to Week 12

Title

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

Description

Time Frame

Baseline (Week 0), up to Week 12

Title

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

Description

Time Frame

Baseline, Weeks 1, 4, 8, and 12

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Potentially Clinically Significant Laboratory (Serum Chemistry, Hematology, and Urinalysis) Abnormal Results

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants Who Received Concomitant Medications

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Injection Site Reactions

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Hypersensitivity/Anaphylaxis Reactions

Description

A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Time Frame

Baseline up to Week 12

Title

Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)

Description

Time Frame

Baseline up to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 13834

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Teva Investigational Site 13819

City

Canoga Park

State/Province

California

ZIP/Postal Code

91303

Country

United States

Facility Name

Teva Investigational Site 13811

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Teva Investigational Site 13823

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Teva Investigational Site 13837

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Teva Investigational Site 13814

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80918

Country

United States

Facility Name

Teva Investigational Site 13836

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Teva Investigational Site 13813

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Teva Investigational Site 13821

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510-2483

Country

United States

Facility Name

Teva Investigational Site 13812

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Teva Investigational Site 13810

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Teva Investigational Site 13815

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Teva Investigational Site 13829

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Teva Investigational Site 13830

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

Teva Investigational Site 13840

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Facility Name

Teva Investigational Site 13833

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Teva Investigational Site 13826

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

Teva Investigational Site 13818

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

Teva Investigational Site 13835

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Teva Investigational Site 13832

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89113

Country

United States

Facility Name

Teva Investigational Site 13831

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Teva Investigational Site 13820

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Teva Investigational Site 13827

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Teva Investigational Site 13816

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Teva Investigational Site 13817

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

Teva Investigational Site 13809

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Teva Investigational Site 13839

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Teva Investigational Site 13825

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Teva Investigational Site 13824

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Teva Investigational Site 13841

City

Richmond

State/Province

Texas

ZIP/Postal Code

77307

Country

United States

Facility Name

Teva Investigational Site 13822

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Teva Investigational Site 78120

City

Auchenflower

ZIP/Postal Code

4066

Country

Australia

Facility Name

Teva Investigational Site 78118

City

Clayton

ZIP/Postal Code

3168

Country

Australia

Facility Name

Teva Investigational Site 78123

City

Melbourne

ZIP/Postal Code

3004

Country

Australia

Facility Name

Teva Investigational Site 78122

City

Parkville

ZIP/Postal Code

3050

Country

Australia

Facility Name

Teva Investigational Site 78121

City

Randwick

ZIP/Postal Code

2031

Country

Australia

Facility Name

Teva Investigational Site 11130

City

Calgary

ZIP/Postal Code

T3M 1M4

Country

Canada

Facility Name

Teva Investigational Site 11131

City

Toronto

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

Teva Investigational Site 40030

City

Helsinki

ZIP/Postal Code

00180

Country

Finland

Facility Name

Teva Investigational Site 40031

City

Oulu

ZIP/Postal Code

90100

Country

Finland

Facility Name

Teva Investigational Site 40029

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Teva Investigational Site 32666

City

Berlin

ZIP/Postal Code

10177

Country

Germany

Facility Name

Teva Investigational Site 32667

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Teva Investigational Site 32660

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Teva Investigational Site 32665

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Teva Investigational Site 32662

City

Kiel

ZIP/Postal Code

24149

Country

Germany

Facility Name

Teva Investigational Site 32661

City

Konigstein im Taunus

ZIP/Postal Code

61462

Country

Germany

Facility Name

Teva Investigational Site 32663

City

Rostock

ZIP/Postal Code

18147

Country

Germany

Facility Name

Teva Investigational Site 80124

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Teva Investigational Site 80122

City

Hadera

ZIP/Postal Code

3810101

Country

Israel

Facility Name

Teva Investigational Site 80125

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Teva Investigational Site 80121

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Teva Investigational Site 80123

City

Netanya

ZIP/Postal Code

4244916

Country

Israel

Facility Name

Teva Investigational Site 80120

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Teva Investigational Site 80127

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Teva Investigational Site 80126

City

Tel-Aviv

ZIP/Postal Code

6812509

Country

Israel

Facility Name

Teva Investigational Site 30190

City

Milan

ZIP/Postal Code

20133

Country

Italy

Facility Name

Teva Investigational Site 30192

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Teva Investigational Site 30194

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Teva Investigational Site 30193

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Teva Investigational Site 30191

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

Teva Investigational Site 30189

City

Rome

ZIP/Postal Code

00163

Country

Italy

Facility Name

Teva Investigational Site 38118

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Teva Investigational Site 38119

City

Nijmegen

ZIP/Postal Code

6532 SZ

Country

Netherlands

Facility Name

Teva Investigational Site 38117

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Teva Investigational Site 53380

City

Bialystok

ZIP/Postal Code

15-402

Country

Poland

Facility Name

Teva Investigational Site 53383

City

Krakow

ZIP/Postal Code

31-505

Country

Poland

Facility Name

Teva Investigational Site 53379

City

Krakow

ZIP/Postal Code

33-332

Country

Poland

Facility Name

Teva Investigational Site 53382

City

Lodz

ZIP/Postal Code

90-338

Country

Poland

Facility Name

Teva Investigational Site 53381

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Teva Investigational Site 31211

City

Galdakao.

ZIP/Postal Code

48960

Country

Spain

Facility Name

Teva Investigational Site 31214

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Teva Investigational Site 31213

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Teva Investigational Site 31212

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Facility Name

Teva Investigational Site 31215

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Teva Investigational Site 42047

City

Huddinge

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Teva Investigational Site 42045

City

Vallingby

ZIP/Postal Code

162 68

Country

Sweden

Facility Name

Teva Investigational Site 34224

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Teva Investigational Site 34222

City

Liverpool

ZIP/Postal Code

L9 7LJ

Country

United Kingdom

Facility Name

Teva Investigational Site 34223

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Teva Investigational Site 34220

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Teva Investigational Site 34221

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

We'll reach out to this number within 24 hrs

A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

Episodic Cluster Headache

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial