Maximizing Outcomes in Treating Acute Migraine

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: AXS-07 (MoSEIC meloxicam and rizatriptan); Drug: Meloxicam; Drug: Rizatriptan; Drug: Placebo

• Registration Number: NCT03896009
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-04
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-03-29
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Disposition First Submitted: 2020-12-07
• Results First Submitted: 2022-12-07
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Results First Posted: 2023-08-24
• Disposition First Posted: 2023-08-24
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1594

Inclusion Criteria

• Has an established diagnosis of migraine with or without aura.
• Has experienced an inadequate response to prior acute treatments.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-07	AXS-07 (MoSEIC meloxicam and rizatriptan)	Taken once upon a qualifying migraine
Meloxicam	Meloxicam	Taken once upon a qualifying migraine
Rizatriptan	Rizatriptan	Taken once upon a qualifying migraine
Placebo	Placebo	Taken once upon a qualifying migraine

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Reporting Headache Pain Freedom	Hour 2 following dose administration	Absence of headache pain. AXS-07 vs Placebo.
Percentage of Subjects With Absence of Most Bothersome Symptom	Hour 2 following dose administration	Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.

Trial Locations

Locations (1)

Clinical Research Site; 🇺🇸 Seattle, Washington, United States