Randomized Trial in Adult Participants With Acute Migraines

Phase 3 Completed 1978 enrolled Pfizer

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to test the safety and efficacy of BHV-3500 (zavegepant) versus placebo in the acute treatment of moderate or severe migraine.

Timeline

Start: 2020-10-27
Primary completion: 2021-10-10
Completion: 2021-10-22

Outcome

Met primary endpoint

registry analysis (superiority test); Zavegepant 10 mg vs Placebo; p <0.0001; Stratified Percentage Difference 8.8 (95% CI 4.5 to 13.1) NCT04571060 ↗

registry analysis (superiority test); Zavegepant 10 mg vs Placebo; p = 0.0012; Stratified Percentage Difference 8.7 (95% CI 3.4 to 13.9) NCT04571060 ↗

Publications

Lipton RB, Croop R, Stock DA, Madonia J, Forshaw M, Lovegren M, Mosher L, Coric V, Goadsby PJ. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023 Mar;22(3):209-217. doi: 10.1016/S1474-4422(22)00517-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zavegepant	Small molecule	10 mg	Intranasal