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

Summary

The purpose of the current study is to evaluate the efficacy and safety of Fremanezumab (TEV-48125), in the prevention of CCH in adult participants.

Timeline

Start

2017-01-17

Primary completion

2018-07-18

Completion

2018-07-18

Outcome

Missed primary endpoint

Stopped: “Futility analysis revealed that the primary endpoint is unlikely to be met. There were no safety concerns observed with fremanezumab treatment in the trial.”

registry analysis (other test); Placebo vs Fremanezumab 675/225/225 mg; p = 0.2741; Least square (LS) mean difference 3.5 (95% CI -2.80 to 9.82); NCT02964338 ↗

registry analysis (other test); Placebo vs Fremanezumab 900/225/225 mg; p = 0.3047; LS mean difference -3.3 (95% CI -9.59 to 3.01); NCT02964338 ↗

Drugs

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

Indications