Phase 3
N=706
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT04068051 ↗Enrolled (actual)
706
Serious AEs
1.1%
Results posted
Oct 2023
Primary outcome: Primary: Long-term Safety of Chronic Intermittent Use of AXS-07 — 293; 118; 8; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AXS-07 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Axsome Therapeutics, Inc.
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-term Safety of Chronic Intermittent Use of AXS-07 |
293; 118; 8; 10; 13; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04068051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.