Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: AXS-07

• Registration Number: NCT04068051
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief 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.

Study Timeline

• Study Start: 2019-07-06
• Study First Submitted: 2019-07-27
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-28
• Primary Completion: 2020-09-22
• Study Completion: 2020-09-22
• Disposition First Submitted: 2021-09-14
• Disposition First Submitted QC: 2021-09-14
• Disposition First Posted: 2021-09-16
• Status Verified: 2023-09
• Results First Submitted: 2023-09-15
• Results First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Results First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 706

Inclusion Criteria

• Has participated in a prior study with AXS-07 for the treatment of migraine

Exclusion Criteria

• Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07
• Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AXS-07	AXS-07	-

Primary Outcome Measures

Name	Time	Method
Long-term Safety of Chronic Intermittent Use of AXS-07	Up to 12 months	Long-term safety as measured by: Subjects with any TEAEs; Subjects with suspected to be drug-related TEAEs; Subjects with serious TEAEs; Subjects with TEAEs that led to drug withdrawal; Subjects with TEAEs that led to withdrawal from study; Subjects with TEAEs that resulted in death

Trial Locations

Locations (1)

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