NCT03896009

Maximizing Outcomes in Treating Acute Migraine

MOMENTUM: 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: 1,594 (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 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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	AXS-07 (MoSEIC meloxicam and rizatriptan)	AXS-07 taken once upon onset of a qualifying migraine.
DRUG	Meloxicam	Meloxicam taken once upon onset of a qualifying migraine.
DRUG	Rizatriptan	Rizatriptan taken once upon onset of a qualifying migraine.
DRUG	Placebo	Placebo taken once upon onset of a qualifying migraine.

Timeline

• Start date: 2019-03-04
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2019-03-29
• Last updated: 2023-08-24
• Results posted: 2023-08-24

Locations

85 sites across 1 country: United States

Regulatory

• FDA-regulated drug study