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

Recruitment Status

(See Contacts and Locations)
Verified September 2023 by Axsome Therapeutics, Inc.


Axsome Therapeutics, Inc.

Information Provided by (Responsible Party)

Axsome Therapeutics, Inc. Identifier

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

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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.
  • 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