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

Recruiting in Palo Alto (17 mi)

+81 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

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.

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Treatment Details

Interventions

Fremanezumab (Monoclonal Antibodies)
Placebo (Other)

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Fremanezumab 900/225/225 mgExperimental Treatment1 Intervention

Participants will receive fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.

Group II: Fremanezumab 675 mg/Placebo/PlaceboExperimental Treatment1 Intervention

Participants will receive placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 milligrams (mg) administered as 3 subcutaneous injections (225 mg/1.5 milliliters \[mL\]) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.

Fremanezumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as Ajovy for: