Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

September 15, 2023 updated by: Axsome Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
706

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Long-term Safety of Chronic Intermittent Use of AXS-07
Time Frame: 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
Up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with headache pain freedom
Time Frame: Hour 2 following dose administration
Absence of headache pain
Hour 2 following dose administration
Proportion of subjects with absence of the most bothersome symptom
Time Frame: Hour 2 following dose administration
Absence of most bothersome symptom, defined at the onset of migraine
Hour 2 following dose administration
Proportion of subjects with headache pain relief
Time Frame: Hour 2 following dose administration
Mild or no headache pain
Hour 2 following dose administration
Proportion of subjects reporting sustained headache pain freedom
Time Frame: Hours 2 through 24 following dose administration
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Axsome Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings