An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor processed this data on April 25, 2024. Link to the current record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified April 2024 by Axsome Therapeutics, Inc.


Axsome Therapeutics, Inc.

Information Provided by (Responsible Party)

Axsome Therapeutics, Inc. Identifier

Other Study ID Numbers: AXS-07-304
First Submitted: September 19, 2022
First Posted: September 22, 2022
Last Update Posted: April 26, 2024
Last Verified: April 2024
History of Changes

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Study Description

Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.
Condition or Disease Intervention/Treatment
  • Migraine
  • Drug: AXS-07 (meloxicam-rizatriptan)

Study Design

Study TypeInterventional
Anticipated Enrollment100 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor
Study Start DateAugust 31, 2022
Anticipated Primary Completion DateDecember 2024
Anticipated Study Completion DateDecember 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • AXS-07 (meloxicam-rizatriptan)
    • Up to 8 weeks
  • Drug: AXS-07 (meloxicam-rizatriptan)
    • AXS-07 tablets, taken orally for the acute treatment of migraine

Outcome Measures

Primary Outcome Measures

  1. Percentage of subjects with headache pain relief [Hour 2 following dose administration]
    Absence of headache pain and without the use of rescue medication.
  2. Percentage of subjects with absence of the Most Bothersome Symptom [Hour 2 following dose administration]
    Absence of the most bothersome symptom, defined at the onset of migraine.

Eligibility Criteria

Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
Inclusion Criteria
  • Has an established diagnosis of migraine with or without aura
  • Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine
Exclusion Criteria
  • Pregnant, breastfeeding, or planning to become pregnant during the study
  • Has previously received any investigational drug or device or investigational therapy within 30 days before Screening

Contacts and Locations

Sponsors and Collaborators Axsome Therapeutics, Inc.
  • Clinical Research Site | Colton, California, United States, 92324
  • Clinical Research Site | Fullerton, California, United States, 92835
  • Clinical Research Site | La Jolla, California, United States, 92037
  • Clinical Research Site | Los Angeles, California, United States, 90067
  • Clinical Research Site | Sherman Oaks, California, United States, 91403
  • Clinical Research Site | Stamford, Connecticut, United States, 06905
  • Clinical Research Site | Coral Gables, Florida, United States, 33134
  • Clinical Research Site | DeLand, Florida, United States, 32720
  • Clinical Research Site | Hallandale Beach, Florida, United States, 33009
  • Clinical Research Site | Ormond Beach, Florida, United States, 31274
  • Clinical Research Site | Oviedo, Florida, United States, 32765
  • Clinical Research Site | Pensacola, Florida, United States, 32504
  • Clinical Research Site | Sunrise, Florida, United States, 33351
  • Clinical Research Site | Winter Park, Florida, United States, 32789
  • Clinical Research Site | Stockbridge, Georgia, United States, 30281
  • Clinical Research Site | Avon, Indiana, United States, 46123
  • Clinical Research Site | Boston, Massachusetts, United States, 02131
  • Clinical Research Site | North Dartmouth, Massachusetts, United States, 02747
  • Clinical Research Site | Las Vegas, Nevada, United States, 89102
  • Clinical Research Site | Albuquerque, New Mexico, United States, 87102
  • Clinical Research Site | Bronx, New York, United States, 10466
  • Clinical Research Site | Williamsville, New York, United States, 14221
  • Clinical Research Site | High Point, North Carolina, United States, 27262
  • Clinical Research Site | Philadelphia, Pennsylvania, United States, 19114
  • Clinical Research Site | Charleston, South Carolina, United States, 29406
  • Clinical Research Site | Knoxville, Tennessee, United States, 37909
  • Clinical Research Site | Nashville, Tennessee, United States, 37203
  • Clinical Research Site | Cypress, Texas, United States, 77429
  • Clinical Research Site | Sugar Land, Texas, United States, 77478
  • Clinical Research Site | Salt Lake City, Utah, United States, 84107
  • Clinical Research Site | Charlottesville, Virginia, United States, 22911
  • Clinical Research Site | McLean, Virginia, United States, 22101

More Information

Additional Information

Additional Relevant MeSH Terms

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