drugset / Trial / NCT04163185

Initiating Early Control of Migraine Pain and Associated Symptoms

NCT04163185

Phase 3 Completed 302 enrolled Axsome Therapeutics, Inc.
RandomizedParallel-groupDouble-blindTreatment

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 placebo. This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.

Timeline

Start
2019-10-08
Primary completion
2020-03-16
Completion
2020-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Meloxicam Small molecule Oral
Subject rizatriptan Unknown Oral

Indications