An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEICâ„¢ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

ClinicalTrials.gov processed this data on September 15, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified September 2023 by Axsome Therapeutics, Inc.

Sponsor

Axsome Therapeutics, Inc.

Information Provided by (Responsible Party)

Axsome Therapeutics, Inc.

Clinicaltrials.gov Identifier

NCT04068051
Other Study ID Numbers: AXS-07-302
First Submitted: July 27, 2019
First Posted: August 28, 2019
Results First Posted: October 10, 2023
Last Update Posted: October 10, 2023
Last Verified: September 2023
History of Changes

Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.

Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.

Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.

For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.

See also the Web Policies and Notices for the NIH web site.

Study 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.
Condition or Disease Intervention/Treatment
  • Migraine
  • Drug: AXS-07

Study Design

Study TypeInterventional
Actual Enrollment706 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEICâ„¢ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
Study Start DateJuly 6, 2019
Actual Primary Completion DateSeptember 22, 2020
Actual Study Completion DateSeptember 22, 2020

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • AXS-07
  • Drug: AXS-07
    • AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Ages Eligible for Study 18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
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

Contacts and Locations

Sponsors and Collaborators Axsome Therapeutics, Inc.
Locations
  • Clinical Research Site | Birmingham, Alabama, United States, 32516
  • Clinical Research Site | Birmingham, Alabama, United States, 32542
  • Clinical Research Site | Mobile, Alabama, United States, 36608
  • Clinical Research Site | Phoenix, Arizona, United States, 85004
  • Clinical Research Site | 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 | 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 | Stockbridge, Georgia, United States, 30281
  • Clinical Research Site | Evanston, Illinois, United States, 60201
  • Clinical Research Site | Louisville, Kentucky, United States, 40213
  • Clinical Research Site | 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 | Ann Arbor, Michigan, United States, 48104
  • Clinical Research Site | Minneapolis, Minnesota, United States, 55402
  • Clinical Research Site | Springfield, Missouri, United States, 65810
  • Clinical Research Site | Las Vegas, Nevada, United States, 89102
  • Clinical Research Site | Albuquerque, New Mexico, United States, 87102
  • Clinical Research Site | 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 | High Point, North Carolina, United States, 27262
  • Clinical Research Site | Cincinnati, Ohio, United States, 45212
  • Clinical Research Site | Columbus, Ohio, United States, 43213
  • Clinical Research Site | Oklahoma City, Oklahoma, United States, 73106
  • Clinical Research Site | Portland, Oregon, United States, 97214
  • Clinical Research Site | Salem, Oregon, United States, 97301
  • Clinical Research Site | Philadelphia, Pennsylvania, United States, 19114
  • Clinical Research Site | Charleston, South Carolina, United States, 29406
  • Clinical Research Site | Mount Pleasant, South Carolina, United States, 29464
  • Clinical Research Site | Knoxville, Tennessee, United States, 37920
  • Clinical Research Site | Memphis, Tennessee, United States, 38119
  • Clinical Research Site | Austin, Texas, United States, 78731
  • Clinical Research Site | Salt Lake City, Utah, United States, 84107
  • Clinical Research Site | Charlottesville, Virginia, United States, 22911
  • Clinical Research Site | Seattle, Washington, United States, 98105

Study Documents (Full Text)

More Information

Additional Relevant MeSH Terms

  • Migraine Disorders
  • Headache Disorders, Primary
  • Headache Disorders
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases