A Study Comparing the Efficacy and Safety of Fremanezumab (TEV-48125) for the Prevention of Chronic Cluster Headache (CCH)

Inclusion Criteria:

• The participant has a history of CCH according to the International Classification ofHeadache Disorders - 3 beta criteria (Headache Classification Committee of theInternational Headache Society [IHS] 2013) for greater than or equal to (≥)12 monthsprior 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 theduration of the study.
• Men must be sterile, or if they are potentially fertile/reproductively competent (notsurgically [for example, vasectomy] or congenitally sterile) and their female partnersare 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 isconsidered as having ≥2 cycles of Botox prior to screening. The participant should notreceive Botox during the run-in period up to the evaluation period (12 weeks) wherethe 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 treatmentof the current cluster headache (CH) cycle within less than or equal to (≤)7 daysprior 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 psychiatricissues 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 3months or 5 half-lives before administration of the first dose of the investigationalmedicinal product (IMP), whichever is longer, unless it is known that the participantreceived placebo during the study.
• The participant has a history of prior exposure to a monoclonal antibody targeting thecalcitonin gene-related peptide (CGRP) pathway (AMG 334, ALD304, LY2951742, orfremanezumab). If participant has participated in a clinical study with any of thesemonoclonal antibodies, it has to be confirmed that the participant received placebo inorder to be eligible for this study.
• The participant is an employee of the sponsor/participating study center who isdirectly involved in the study or is the relative of such an employee.
• The participant has an active implant for neurostimulation used in the treatment ofCH.
• The participant is a member of a vulnerable population (for example, people kept indetention).
• The participant has a history of alcohol abuse prior to screening and/or drug abusethat in the Investigator's opinion could interfere with the study evaluations or theparticipant's safety.
• Additional criteria apply, please contact the Investigator for more information.