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

NCT ID: NCT02945046

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-19
• Study Completion Date: 2019-05-13

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.

Conditions

Episodic Cluster Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Fremanezumab

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Fremanezumab

Intervention Type: DRUG

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

Interventions

Fremanezumab

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

TEV-48125

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 13834

Phoenix, Arizona, United States

Teva Investigational Site 13819

Canoga Park, California, United States

Teva Investigational Site 13811

Santa Monica, California, United States

Teva Investigational Site 13823

Stanford, California, United States

Teva Investigational Site 13837

Aurora, Colorado, United States

Teva Investigational Site 13814

Colorado Springs, Colorado, United States

Teva Investigational Site 13836

Denver, Colorado, United States

Teva Investigational Site 13813

Englewood, Colorado, United States

Teva Investigational Site 13821

New Haven, Connecticut, United States

Teva Investigational Site 13812

Stamford, Connecticut, United States

Teva Investigational Site 13810

Gainesville, Florida, United States

Teva Investigational Site 13815

Orlando, Florida, United States

Teva Investigational Site 13829

Ormond Beach, Florida, United States

Teva Investigational Site 13830

St. Petersburg, Florida, United States

Teva Investigational Site 13840

Tampa, Florida, United States

Teva Investigational Site 13833

Columbus, Georgia, United States

Teva Investigational Site 13826

Chicago, Illinois, United States

Teva Investigational Site 13818

Ann Arbor, Michigan, United States

Teva Investigational Site 13835

Las Vegas, Nevada, United States

Teva Investigational Site 13832

Las Vegas, Nevada, United States

Teva Investigational Site 13831

Lebanon, New Hampshire, United States

Teva Investigational Site 13820

Princeton, New Jersey, United States

Teva Investigational Site 13827

Albuquerque, New Mexico, United States

Teva Investigational Site 13816

Amherst, New York, United States

Teva Investigational Site 13817

New York, New York, United States

Teva Investigational Site 13809

Raleigh, North Carolina, United States

Teva Investigational Site 13839

Salisbury, North Carolina, United States

Teva Investigational Site 13825

Cleveland, Ohio, United States

Teva Investigational Site 13824

Philadelphia, Pennsylvania, United States

Teva Investigational Site 13841

Richmond, Texas, United States

Teva Investigational Site 13822

Virginia Beach, Virginia, United States

Teva Investigational Site 78120

Auchenflower, , Australia

Teva Investigational Site 78118

Clayton, , Australia

Teva Investigational Site 78123

Melbourne, , Australia

Teva Investigational Site 78122

Parkville, , Australia

Teva Investigational Site 78121

Randwick, , Australia

Teva Investigational Site 11130

Calgary, , Canada

Teva Investigational Site 11131

Toronto, , Canada

Teva Investigational Site 40030

Helsinki, , Finland

Teva Investigational Site 40031

Oulu, , Finland

Teva Investigational Site 40029

Turku, , Finland

Teva Investigational Site 32666

Berlin, , Germany

Teva Investigational Site 32667

Bochum, , Germany

Teva Investigational Site 32660

Essen, , Germany

Teva Investigational Site 32665

Hamburg, , Germany

Teva Investigational Site 32662

Kiel, , Germany

Teva Investigational Site 32661

Königstein im Taunus, , Germany

Teva Investigational Site 32663

Rostock, , Germany

Teva Investigational Site 80124

Ashkelon, , Israel

Teva Investigational Site 80122

Hadera, , Israel

Teva Investigational Site 80125

Holon, , Israel

Teva Investigational Site 80121

Jerusalem, , Israel

Teva Investigational Site 80123

Netanya, , Israel

Teva Investigational Site 80120

Ramat Gan, , Israel

Teva Investigational Site 80127

Tel Aviv, , Israel

Teva Investigational Site 80126

Tel Aviv, , Israel

Teva Investigational Site 30190

Milan, , Italy

Teva Investigational Site 30192

Modena, , Italy

Teva Investigational Site 30194

Napoli, , Italy

Teva Investigational Site 30193

Pavia, , Italy

Teva Investigational Site 30191

Rome, , Italy

Teva Investigational Site 30189

Rome, , Italy

Teva Investigational Site 38118

Leiden, , Netherlands

Teva Investigational Site 38119

Nijmegen, , Netherlands

Teva Investigational Site 38117

Zwolle, , Netherlands

Teva Investigational Site 53380

Bialystok, , Poland

Teva Investigational Site 53383

Krakow, , Poland

Teva Investigational Site 53379

Krakow, , Poland

Teva Investigational Site 53382

Lodz, , Poland

Teva Investigational Site 53381

Szczecin, , Poland

Teva Investigational Site 31211

Galdakao, , Spain

Teva Investigational Site 31214

Madrid, , Spain

Teva Investigational Site 31213

Seville, , Spain

Teva Investigational Site 31212

Valladolid, , Spain

Teva Investigational Site 31215

Zaragoza, , Spain

Teva Investigational Site 42047

Huddinge, , Sweden

Teva Investigational Site 42045

Vällingby, , Sweden

Teva Investigational Site 34224

Glasgow, , United Kingdom

Teva Investigational Site 34222

Liverpool, , United Kingdom

Teva Investigational Site 34223

London, , United Kingdom

Teva Investigational Site 34220

London, , United Kingdom

Teva Investigational Site 34221

Oxford, , United Kingdom

Countries

United States; Australia; Canada; Finland; Germany; Israel; Italy; Netherlands; Poland; Spain; Sweden; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-003278-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV48125-CNS-30056

Identifier Type: -

Identifier Source: org_study_id