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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: AXS-07

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 Type: Interventional
• Enrollment (Actual): 706
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 32516
      • Clinical Research Site
    • Birmingham, Alabama, United States, 32542
      • Clinical Research Site
    • Mobile, Alabama, United States, 36608
      • Clinical Research Site
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Clinical Research Site
  • California
    • Canoga Park, California, United States, 91303
      • Clinical Research Site
    • Colton, California, United States, 92324
      • Clinical Research Site
    • Encino, California, United States, 91316
      • Clinical Research Site
    • Los Alamitos, California, United States, 90720
      • Clinical Research Site
    • Los Angeles, California, United States, 90017
      • Clinical Research Site
    • Los Angeles, California, United States, 90048
      • Clinical Research Site
    • San Diego, California, United States, 92103
      • Clinical Research Site
    • Spring Valley, California, United States, 91978
      • Clinical Research Site
    • Walnut Creek, California, United States, 94598
      • Clinical Research Site
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • Clinical Research Site
    • Jacksonville, Florida, United States, 32256
      • Clinical Research Site
    • Lake City, Florida, United States, 32055
      • Clinical Research Site
    • Lake Worth, Florida, United States, 33467
      • Clinical Research Site
    • Miami, Florida, United States, 33155
      • Clinical Research Site
    • Ocoee, Florida, United States, 34761
      • Clinical Research Site
    • Orlando, Florida, United States, 32801
      • Clinical Research Site
    • Ormond Beach, Florida, United States, 32174
      • Clinical Research Site
    • Tampa, Florida, United States, 33634
      • Clinical Research Site
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Site
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Clinical Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Clinical Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Clinical Research Site
    • North Dartmouth, Massachusetts, United States, 02747
      • Clinical Research Site
    • Waltham, Massachusetts, United States, 02451
      • Clinical Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Clinical Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Site
  • Missouri
    • Springfield, Missouri, United States, 65810
      • Clinical Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Clinical Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Clinical Research Site
  • New York
    • Manlius, New York, United States, 13104
      • Clinical Research Site
    • Rochester, New York, United States, 14609
      • Clinical Research Site
    • Williamsville, New York, United States, 14221
      • Clinical Research Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Clinical Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Clinical Research Site
    • Columbus, Ohio, United States, 43213
      • Clinical Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • Clinical Research Site
  • Oregon
    • Portland, Oregon, United States, 97214
      • Clinical Research Site
    • Salem, Oregon, United States, 97301
      • Clinical Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Clinical Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Clinical Research Site
    • Memphis, Tennessee, United States, 38119
      • Clinical Research Site
  • Texas
    • Austin, Texas, United States, 78731
      • Clinical Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Clinical Research Site
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Clinical Research Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AXS-07	Drug: AXS-07; AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with headache pain freedom	Absence of headache pain	Hour 2 following dose administration
Proportion of subjects with absence of the most bothersome symptom	Absence of most bothersome symptom, defined at the onset of migraine	Hour 2 following dose administration
Proportion of subjects with headache pain relief	Mild or no headache pain	Hour 2 following dose administration
Proportion of subjects reporting sustained headache pain freedom	Sustained headache pain freedom without use of rescue medication and no relapse of headache pain	Hours 2 through 24 following dose administration

Collaborators and Investigators

• Sponsor: Axsome Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2019
• Primary Completion (Actual): September 22, 2020
• Study Completion (Actual): September 22, 2020

Study Registration Dates

• First Submitted: July 27, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Axsome; AXS-07; rizatriptan; MoSEIC™ meloxicam
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: AXS-07-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No