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

TERMINATEDPHASE3

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

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

NCT02945046•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

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.
+3 more criteria

Locations (82)

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

Key Dates

Start Date

January 19, 2017

Primary Completion Date

May 13, 2019

Completion Date

May 13, 2019

Last Updated

November 9, 2021

Enrollment

169

ACTUAL participants

Conditions

Episodic Cluster Headache

Interventions

Fremanezumab

DRUG

Placebo

DRUG

R-Verapamil for the Prophylaxis of Episodic Cluster Headache

NCT02209155

Episodic Cluster Headache

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COMPLETEDPHASE3

A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache

NCT00033839

Episodic Cluster Headache

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UNKNOWNPHASE4

Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache

NCT00399243

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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