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

Inclusion Criteria:

- The patient has a history of ECH according to the International Classification of
Headache Disorders - 3 beta criteria (Headache Classification Committee of the IHS
2013) for ≥12 months prior to screening

- The patient has a total body weight of ≥45 kg (99 lbs.)

- The patient is in good health in the opinion of the investigator

- Women of childbearing potential (WOCBP) whose male partners are potentially fertile
(ie, 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 [eg, 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 patient is receiving Botox, it should be in a stable dose regimen, considered as
having ≥2 cycles of Botox prior to screening. The patient 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 patient has used systemic steroids for any medical reason (including treatment of
the current CH cycle within ≤7 days prior to screening The patient has used an
intervention/device (eg, scheduled nerve blocks) for headache during the 4 weeks prior
to screening.

- The patient has clinically significant hematological, renal, endocrine, immunologic,
pulmonary, gastrointestinal, genitourinary, cardiovascular, neurologic, hepatic, or
ocular disease at the discretion of the investigator.

- The patient has evidence or medical history of clinically significant psychiatric
issues determined at the discretion of the investigator.

- The patient 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 patient is pregnant or lactating.

- The patient has a history of hypersensitivity reactions to injected proteins,
including monoclonal antibodies.

- The patient 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 patient received placebo during the study.

- The patient 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 patient has participated in a clinical study with any of these
monoclonal antibodies, it has to be confirmed that the patient received placebo in
order to be eligible for this study.

- The patient 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 patient has an active implant for neurostimulation used in the treatment of CH.

- The patient is a member of a vulnerable population (eg, people kept in detention).

- The patient 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
patient's safety .

- Additional criteria apply, please contact the investigator for more information