NCT04068051

Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC™ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 706 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.

Detailed description

This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	AXS-07	AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.

Timeline

• Start date: 2019-07-06
• Primary completion: 2020-09-22
• Completion: 2020-09-22
• First posted: 2019-08-28
• Last updated: 2023-10-10
• Results posted: 2023-10-10

Locations

51 sites across 1 country: United States

Regulatory

• FDA-regulated drug study