Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

Last updated: January 16, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Oral Facial Pain

Pain

Chronic Pain

Treatment

AXS-07 (meloxicam-rizatriptan)

Clinical Study ID

NCT05550207
AXS-07-304
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has an established diagnosis of migraine with or without aura

  • Has experienced an inadequate response to oral CGRP inhibitors for the acutetreatment of migraine

Exclusion

Exclusion Criteria:

  • Pregnant, breastfeeding, or planning to become pregnant during the study

  • Has previously received any investigational drug or device or investigationaltherapy within 30 days before Screening

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: AXS-07 (meloxicam-rizatriptan)
Phase: 3
Study Start date:
August 31, 2022
Estimated Completion Date:
November 27, 2024

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.

Connect with a study center

  • Clinical Research Site

    Colton, California 92324
    United States

    Site Not Available

  • Clinical Research Site

    Fullerton, California 92835
    United States

    Site Not Available

  • Clinical Research Site

    La Jolla, California 92037
    United States

    Site Not Available

  • Clinical Research Site

    Los Angeles, California 90067
    United States

    Site Not Available

  • Clinical Research Site

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Clinical Research Site

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Clinical Research Site

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Clinical Research Site

    DeLand, Florida 32720
    United States

    Site Not Available

  • Clinical Research Site

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Clinical Research Site

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Clinical Research Site

    Miami, Florida 33126
    United States

    Site Not Available

  • Clinical Research Site

    Ormond Beach, Florida 31274
    United States

    Site Not Available

  • Clinical Research Site

    Oviedo, Florida 32765
    United States

    Site Not Available

  • Clinical Research Site

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Clinical Research Site

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Clinical Research Site

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Clinical Research Site

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Clinical Research Site

    Avon, Indiana 46123
    United States

    Site Not Available

  • Clinical Research Site

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Clinical Research Site

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Clinical Research Site

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Clinical Research Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Clinical Research Site

    Bronx, New York 10466
    United States

    Site Not Available

  • Clinical Research Site

    Williamsville, New York 14221
    United States

    Site Not Available

  • Clinical Research Site

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Clinical Research Site

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Clinical Research Site

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Clinical Research Site

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Clinical Research Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Clinical Research Site

    Cypress, Texas 77429
    United States

    Site Not Available

  • Clinical Research Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Clinical Research Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Clinical Research Site

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Clinical Research Site

    McLean, Virginia 22101
    United States

    Site Not Available

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