A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

ClinicalTrials.gov processed this data on April 28, 2021. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED (See Contacts and Locations)
Verified April 2021 by Axsome Therapeutics, Inc.


Axsome Therapeutics, Inc.

Information Provided by (Responsible Party)

Axsome Therapeutics, Inc.

Clinicaltrials.gov Identifier

Other Study ID Numbers: AXS-07-303
First Submitted: November 12, 2019
First Posted: November 14, 2019
Last Update Posted: April 30, 2021
Last Verified: April 2021
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Migraine
  • Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment302 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
Primary PurposeTreatment
Official TitleA Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
Study Start DateOctober 8, 2019
Actual Primary Completion DateMarch 23, 2020
Actual Study Completion DateMarch 23, 2020

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • AXS-07
    • Taken once upon migraine
  • Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
    • AXS-07 tablet taken once upon the earliest onset of migraine pain.
  • Placebo
    • Taken once upon migraine
  • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of subjects reporting headache pain freedom [Hour 2]
      Absence of headache pain
    2. Percentage of subjects with absence of Most Bothersome Symptom [Hour 2]
      Absence of Most Bothersome Symptom, defined at the onset of migraine

    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
    • a:
    • • Has an established diagnosis of migraine with or without aura.
    • Ke
    Exclusion Criteria
    • Has previously received any investigational drug or device or investigational therapy within 30 days before Screening.
    • 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, 35205
    • Clinical Research Site | Birmingham, Alabama, United States, 35216
    • Clinical Research Site | Mobile, Alabama, United States, 36608
    • Clinical Research Site | Colton, California, United States, 92399
    • 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 | Redlands, California, United States, 92374
    • Clinical Research Site | Santa Monica, California, United States, 90404
    • 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 | 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 | South Miami, Florida, United States, 33143
    • Clinical Research Site | Sunrise, Florida, United States, 33351
    • 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 | Waltham, Massachusetts, United States, 02451
    • Clinical Research Site | Ann Arbor, Michigan, United States, 48104
    • Clinical Research Site | Springfield, Missouri, United States, 65810
    • Clinical Research Site | Albuquerque, New Mexico, United States, 87102
    • Clinical Research Site | Manlius, New York, United States, 13104
    • Clinical Research Site | Williamsville, New York, United States, 14221
    • Clinical Research Site | High Point, North Carolina, United States, 27262
    • Clinical Research Site | Oklahoma City, Oklahoma, United States, 73106
    • 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 | Memphis, Tennessee, United States, 38119
    • Clinical Research Site | Nashville, Tennessee, United States, 37203
    • 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

    More Information

    Additional Information

    Additional Relevant MeSH Terms

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