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New migraine pill aims to stop pain in 2 hours

NCT ID NCT04163185

Symptom relief Sponsor: Axsome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a single dose of AXS-07, a combination of meloxicam and rizatriptan, for treating migraines in adults. 302 participants took either the drug or a placebo at the first sign of migraine pain. The study measured how many were pain-free and free of their most bothersome symptom after 2 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AXS-07 (a combination of meloxicam and rizatriptan)
What this could lead to
If it works, this could provide a fast-acting, single-dose option for relieving migraine pain and associated symptoms.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove more effective than placebo, and side effects from the combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

302 people

The number who actually took part.

Started

Oct 2019

Finished

Mar 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • Clinical Research Site

    Birmingham, Alabama, 35205, United States

  • Clinical Research Site

    Birmingham, Alabama, 35216, United States

  • Clinical Research Site

    Mobile, Alabama, 36608, United States

  • Clinical Research Site

    Colton, California, 92399, United States

  • Clinical Research Site

    Encino, California, 91316, United States

  • Clinical Research Site

    Los Alamitos, California, 90720, United States

  • Clinical Research Site

    Los Angeles, California, 90017, United States

  • Clinical Research Site

    Redlands, California, 92374, United States

  • Clinical Research Site

    Santa Monica, California, 90404, United States

  • Clinical Research Site

    Spring Valley, California, 91978, United States

  • Clinical Research Site

    Walnut Creek, California, 94598, United States

  • Clinical Research Site

    Hallandale, Florida, 33009, United States

  • Clinical Research Site

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site

    Lake City, Florida, 32055, United States

  • Clinical Research Site

    Lake Worth, Florida, 33467, United States

  • Clinical Research Site

    Ocoee, Florida, 34761, United States

  • Clinical Research Site

    Orlando, Florida, 32801, United States

  • Clinical Research Site

    Ormond Beach, Florida, 32174, United States

  • Clinical Research Site

    South Miami, Florida, 33143, United States

  • Clinical Research Site

    Sunrise, Florida, 33351, United States

  • Clinical Research Site

    Tampa, Florida, 33634, United States

  • Clinical Research Site

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Site

    Evanston, Illinois, 60201, United States

  • Clinical Research Site

    Louisville, Kentucky, 40213, United States

  • Clinical Research Site

    Boston, Massachusetts, 02131, United States

  • Clinical Research Site

    Waltham, Massachusetts, 02451, United States

  • Clinical Research Site

    Ann Arbor, Michigan, 48104, United States

  • Clinical Research Site

    Springfield, Missouri, 65810, United States

  • Clinical Research Site

    Albuquerque, New Mexico, 87102, United States

  • Clinical Research Site

    Manlius, New York, 13104, United States

  • Clinical Research Site

    Williamsville, New York, 14221, United States

  • Clinical Research Site

    High Point, North Carolina, 27262, United States

  • Clinical Research Site

    Oklahoma City, Oklahoma, 73106, United States

  • Clinical Research Site

    Philadelphia, Pennsylvania, 19114, United States

  • Clinical Research Site

    Charleston, South Carolina, 29406, United States

  • Clinical Research Site

    Mt. Pleasant, South Carolina, 29464, United States

  • Clinical Research Site

    Memphis, Tennessee, 38119, United States

  • Clinical Research Site

    Nashville, Tennessee, 37203, United States

  • Clinical Research Site

    Austin, Texas, 78731, United States

  • Clinical Research Site

    Salt Lake City, Utah, 84107, United States

  • Clinical Research Site

    Charlottesville, Virginia, 22911, United States

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