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
1 other identifier
interventional
706
1 country
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2019
Shorter than P25 for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2019
CompletedFirst Submitted
Initial submission to the registry
July 27, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2020
CompletedResults Posted
Study results publicly available
October 10, 2023
CompletedOctober 10, 2023
September 1, 2023
1.2 years
July 27, 2019
September 15, 2023
September 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term Safety of Chronic Intermittent Use of AXS-07
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
Up to 12 months
Study Arms (1)
AXS-07
EXPERIMENTALInterventions
AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Eligibility Criteria
You may qualify if:
- Has participated in a prior study with AXS-07 for the treatment of migraine
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Clinical Research Site
Birmingham, Alabama, 32516, United States
Clinical Research Site
Birmingham, Alabama, 32542, United States
Clinical Research Site
Mobile, Alabama, 36608, United States
Clinical Research Site
Phoenix, Arizona, 85004, United States
Clinical Research Site
Canoga Park, California, 91303, United States
Clinical Research Site
Colton, California, 92324, United States
Clinical Research Site
Encino, California, 91316, United States
Clinical Research Site
Los Alamitos, California, 90720, United States
Clinical Research Site
Los Angeles, California, 90017, United States
Clinical Research Site
Los Angeles, California, 90048, United States
Clinical Research Site
San Diego, California, 92103, United States
Clinical Research Site
Spring Valley, California, 91978, United States
Clinical Research Site
Walnut Creek, California, 94598, United States
Clinical Research Site
Hallandale, Florida, 33009, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Lake City, Florida, 32055, United States
Clinical Research Site
Lake Worth, Florida, 33467, United States
Clinical Research Site
Miami, Florida, 33155, United States
Clinical Research Site
Ocoee, Florida, 34761, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Ormond Beach, Florida, 32174, United States
Clinical Research Site
Tampa, Florida, 33634, United States
Clinical Research Site
Stockbridge, Georgia, 30281, United States
Clinical Research Site
Evanston, Illinois, 60201, United States
Clinical Research Site
Louisville, Kentucky, 40213, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Site
Waltham, Massachusetts, 02451, United States
Clinical Research Site
Ann Arbor, Michigan, 48104, United States
Clinical Research Site
Minneapolis, Minnesota, 55402, United States
Clinical Research Site
Springfield, Missouri, 65810, United States
Clinical Research Site
Las Vegas, Nevada, 89102, United States
Clinical Research Site
Albuquerque, New Mexico, 87102, United States
Clinical Research Site
Manlius, New York, 13104, United States
Clinical Research Site
Rochester, New York, 14609, United States
Clinical Research Site
Williamsville, New York, 14221, United States
Clinical Research Site
High Point, North Carolina, 27262, United States
Clinical Research Site
Cincinnati, Ohio, 45212, United States
Clinical Research Site
Columbus, Ohio, 43213, United States
Clinical Research Site
Oklahoma City, Oklahoma, 73106, United States
Clinical Research Site
Portland, Oregon, 97214, United States
Clinical Research Site
Salem, Oregon, 97301, United States
Clinical Research Site
Philadelphia, Pennsylvania, 19114, United States
Clinical Research Site
Charleston, South Carolina, 29406, United States
Clinical Research Site
Mt. Pleasant, South Carolina, 29464, United States
Clinical Research Site
Knoxville, Tennessee, 37920, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Austin, Texas, 78731, United States
Clinical Research Site
Salt Lake City, Utah, 84107, United States
Clinical Research Site
Charlottesville, Virginia, 22911, United States
Clinical Research Site
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Caroline Streicher, Vice President, Clinical Operations
- Organization
- Axsome Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2019
First Posted
August 28, 2019
Study Start
July 6, 2019
Primary Completion
September 22, 2020
Study Completion
September 22, 2020
Last Updated
October 10, 2023
Results First Posted
October 10, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share