Maximizing Outcomes in Treating Acute Migraine

Summary

AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to meloxicam, rizatriptan, and placebo for the treatment of a migraine attack. This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.

Timeline

Start

2019-03-04

Primary completion

2019-12-10

Completion

2019-12-10

Outcome

Met primary endpoint

release “met the two regulatory co-primary endpoints and significantly improved migraine pain and most bothersome symptoms as compared to placebo in the MOMENTUM Phase 3 trial.” gcs-web.com ↗

Drugs

Indications