Phase 3 N=302 Randomized Double-blind Treatment

Initiating Early Control of Migraine Pain and Associated Symptoms

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT04163185 ↗

Enrolled (actual)

302

Serious AEs

0.0%

Results posted

Jan 2026

Primary outcome: Primary: Percentage of Subjects Achieving Headache Pain Freedom at Hour 2 — 43; 22 Participants — p=0.002

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: AXS-07 (MoSEIC meloxicam and rizatriptan) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Axsome Therapeutics, Inc.
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Achieving Headache Pain Freedom at Hour 2	43; 22	0.002 sig
PRIMARY Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2	58; 36	0.003 sig

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.

Eligibility Criteria

Key Inclusion Criteria

Has an established diagnosis of migraine with or without aura.

Key Exclusion Criteria

Has previously received any investigational drug or device or investigational therapy within 30 days before Screening.
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04163185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.