NCT04163185

Initiating Early Control of Migraine Pain and Associated Symptoms

A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	AXS-07 (MoSEIC meloxicam and rizatriptan)	AXS-07 tablet taken once upon the earliest onset of migraine pain.
DRUG	Placebo	Placebo tablet taken once upon the earliest onset of migraine pain.

Timeline

• Start date: 2019-10-08
• Primary completion: 2020-03-16
• Completion: 2020-03-23
• First posted: 2019-11-14
• Last updated: 2026-01-28
• Results posted: 2026-01-28

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study