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

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.

Timeline

Start

2017-01-19

Primary completion

2019-05-13

Completion

2019-05-13

Outcome

Missed primary endpoint

Stopped: “Study was terminated as a result of a pre-specified futility analysis at the interim of 150 participants completing the efficacy analysis of the study.”

registry analysis (other test); Fremanezumab 675 mg/Placebo/Placebo; p = 0.9093; LS mean difference -0.1 (95% CI -2.72 to 2.42) NCT02945046 ↗

registry analysis (other test); Fremanezumab 900/225/225 mg; p = 0.1345; LS mean difference -1.9 (95% CI -4.49 to 0.61) NCT02945046 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fremanezumab	Monoclonal antibody	225 mg	Intravenous
Subject	Fremanezumab	Monoclonal antibody	675 mg	Intravenous
Subject	Fremanezumab	Monoclonal antibody	900 mg	Intravenous

Indications