MigrainePhase 3NCT05550207
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)
A Phase 3 study testing AXS-07 (meloxicam-rizatriptan) in people with Migraine, run by Axsome Therapeutics, Inc. at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- AXS-07 (meloxicam-rizatriptan)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 31 sitesUnited States
- Study dates
- 31 Aug 2022to 27 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Clinical Research Site
Albuquerque, New Mexico, 87102
Clinical Research Site
Avon, Indiana, 46123
Clinical Research Site
Boston, Massachusetts, 02131
Clinical Research Site
Charleston, South Carolina, 29406
Clinical Research Site
Charlottesville, Virginia, 22911
Clinical Research Site
Colton, California, 92324
Clinical Research Site
Cypress, Texas, 77429
Clinical Research Site
DeLand, Florida, 32720
Clinical Research Site
Fullerton, California, 92835
Clinical Research Site
Hallandale, Florida, 33009
Clinical Research Site
Hollywood, Florida, 33024
Clinical Research Site
Knoxville, Tennessee, 37909
Clinical Research Site
La Jolla, California, 92037
Clinical Research Site
Las Vegas, Nevada, 89102
Clinical Research Site
Los Angeles, California, 90067
Clinical Research Site
McLean, Virginia, 22101
Clinical Research Site
Miami, Florida, 33126
Clinical Research Site
Nashville, Tennessee, 37203
Clinical Research Site
North Dartmouth, Massachusetts, 02747
Clinical Research Site
Ormond Beach, Florida, 31274
Clinical Research Site
Oviedo, Florida, 32765
Clinical Research Site
Pensacola, Florida, 32504
Clinical Research Site
Philadelphia, Pennsylvania, 19114
Clinical Research Site
Salt Lake City, Utah, 84107
Clinical Research Site
Sherman Oaks, California, 91403
Clinical Research Site
Stamford, Connecticut, 06905
Clinical Research Site
Stockbridge, Georgia, 30281
Clinical Research Site
Sugar Land, Texas, 77478
Clinical Research Site
The Bronx, New York, 10466
Clinical Research Site
Williamsville, New York, 14221
Clinical Research Site
Winter Park, Florida, 32789
About this study
Official title: 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
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.
Read the detailed description
Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.
- Conditions
- Migraine
- Being tested
- AXS-07 (meloxicam-rizatriptan)
- Keywords
- Migraine, AXS-07, Meloxicam, Rizatriptan, Oral CGRP inhibitor
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-07 (meloxicam-rizatriptan)Drug
AXS-07 tablets, taken orally for the acute treatment of migraine
| Study group | Role | What they receive |
|---|---|---|
| AXS-07 (meloxicam-rizatriptan) | Experimental | Up to 8 weeks Receives: Drug: AXS-07 (meloxicam-rizatriptan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with headache pain relief
Absence of headache pain and without the use of rescue medication.
Measured: Hour 2 following dose administration
Percentage of subjects with absence of the Most Bothersome Symptom
Absence of the most bothersome symptom, defined at the onset of migraine.
Measured: Hour 2 following dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start31 Aug 2022
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550207
- Sponsor's protocol ID
- AXS-07-304
- Status last verified
- Nov 2025
- First submitted
- 19 Sep 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05550207
- Acronym / sponsor ID
- AXS-07-304
- Conditions
- Migraine
- Keywords
- Migraine, AXS-07, Meloxicam, Rizatriptan, Oral CGRP inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AXS-07 (meloxicam-rizatriptan) | Experimental | Drug: AXS-07 (meloxicam-rizatriptan)Up to 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXS-07 (meloxicam-rizatriptan)AXS-07 tablets, taken orally for the acute treatment of migraine | Drug | AXS-07 (meloxicam-rizatriptan) |
Primary outcome
Percentage of subjects with headache pain relief
Time frame: Hour 2 following dose administration
Absence of headache pain and without the use of rescue medication.
Percentage of subjects with absence of the Most Bothersome Symptom
Time frame: Hour 2 following dose administration
Absence of the most bothersome symptom, defined at the onset of migraine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AXS-07 (meloxicam-rizatriptan) in people with Migraine, run by Axsome Therapeutics, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with headache pain relief (time frame: Hour 2 following dose administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.