NCT05550207

Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.

Detailed description

Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	AXS-07 (meloxicam-rizatriptan)	AXS-07 tablets, taken orally for the acute treatment of migraine

Timeline

• Start date: 2022-08-31
• Primary completion: 2024-11-27
• Completion: 2024-11-27
• First posted: 2022-09-22
• Last updated: 2025-12-02

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study