a study to evaluate the efficacy and safety of tev-48125 (fremanezumab) for the prevention of episodic cluster headache (ech)

Conditions: Episodic Cluster Headache

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 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