Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 706
- Has participated in a prior study with AXS-07 for the treatment of migraine
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸Seattle, Washington, United States