a study comparing the efficacy and safety of fremanezumab (tev-48125) for the prevention of chronic cluster headache (cch)

Conditions: Chronic Cluster Headache

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.


Eligibility criteria:
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. 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.