Initiating Early Control of Migraine Pain and Associated Symptoms (INTERCEPT)

January 12, 2026 updated by: Axsome Therapeutics, Inc.

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

AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to placebo.

This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Clinical Research Site
      • Birmingham, Alabama, United States, 35216
        • Clinical Research Site
      • Mobile, Alabama, United States, 36608
        • Clinical Research Site
    • California
      • 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
    • Florida
      • Hallandale, 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
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Site
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Clinical Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Clinical Research Site
      • Waltham, Massachusetts, United States, 02451
        • Clinical Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Clinical Research Site
    • Missouri
      • Springfield, Missouri, United States, 65810
        • Clinical Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Clinical Research Site
    • New York
      • Manlius, New York, United States, 13104
        • Clinical Research Site
      • Williamsville, New York, United States, 14221
        • Clinical Research Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Clinical Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • Clinical Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Research Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Clinical Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Research Site
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Clinical Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Clinical Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

• Has an established diagnosis of migraine with or without aura.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 Comparator: Placebo
Taken once upon migraine
Drug: Placebo
Placebo tablet taken once upon the earliest onset of migraine pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Headache Pain Freedom at Hour 2
Time Frame: Hour 2
Absence of headache pain at Hour 2
Hour 2
Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2
Time Frame: Hour 2
Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2
Hour 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2019

Primary Completion (Actual)

March 16, 2020

Study Completion (Actual)

March 23, 2020

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-07-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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