A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)
Condition: Episodic Cluster Headache
MeSH terms: Cluster Headache; Headache
Intervention: Fremanezumab; Placebo
Intervention description: Fremanezumab will be administered per dose and schedule specified in the arm.; Placebo matching to fremanezumab will be administered per schedule specified in the arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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