MigrainePhase 3INTERCEPTNCT04163185

Initiating Early Control of Migraine Pain and Associated Symptoms

A Phase 3 study testing AXS-07 (MoSEIC meloxicam and rizatriptan) in people with Migraine, run by Axsome Therapeutics, Inc. at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine
What is being tested?: AXS-07 (MoSEIC meloxicam and rizatriptan)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 302 participants
Where: 41 sitesUnited States
Study dates: 8 Oct 2019to 23 Mar 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has an established diagnosis of migraine with or without aura.

Who cannot join

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.

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Clinical Research Site
Albuquerque, New Mexico, 87102
Clinical Research Site
Ann Arbor, Michigan, 48104
Clinical Research Site
Austin, Texas, 78731
Clinical Research Site
Birmingham, Alabama, 35205
Clinical Research Site
Birmingham, Alabama, 35216
Clinical Research Site
Boston, Massachusetts, 02131
Clinical Research Site
Charleston, South Carolina, 29406
Clinical Research Site
Charlottesville, Virginia, 22911
Clinical Research Site
Colton, California, 92399
Clinical Research Site
Encino, California, 91316
Clinical Research Site
Evanston, Illinois, 60201
Clinical Research Site
Hallandale, Florida, 33009
Clinical Research Site
High Point, North Carolina, 27262
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Lake City, Florida, 32055
Clinical Research Site
Lake Worth, Florida, 33467
Clinical Research Site
Los Alamitos, California, 90720
Clinical Research Site
Los Angeles, California, 90017
Clinical Research Site
Louisville, Kentucky, 40213
Clinical Research Site
Manlius, New York, 13104
Clinical Research Site
Memphis, Tennessee, 38119
Clinical Research Site
Mobile, Alabama, 36608
Clinical Research Site
Mt. Pleasant, South Carolina, 29464
Clinical Research Site
Nashville, Tennessee, 37203
Clinical Research Site
Ocoee, Florida, 34761
Clinical Research Site
Oklahoma City, Oklahoma, 73106
Clinical Research Site
Orlando, Florida, 32801
Clinical Research Site
Ormond Beach, Florida, 32174
Clinical Research Site
Philadelphia, Pennsylvania, 19114
Clinical Research Site
Redlands, California, 92374
Clinical Research Site
Salt Lake City, Utah, 84107
Clinical Research Site
Santa Monica, California, 90404
Clinical Research Site
South Miami, Florida, 33143
Clinical Research Site
Spring Valley, California, 91978
Clinical Research Site
Springfield, Missouri, 65810
Clinical Research Site
Stockbridge, Georgia, 30281
Clinical Research Site
Sunrise, Florida, 33351
Clinical Research Site
Tampa, Florida, 33634
Clinical Research Site
Walnut Creek, California, 94598
Clinical Research Site
Waltham, Massachusetts, 02451
Clinical Research Site
Williamsville, New York, 14221

Other trials in United States

About this study

Official title: 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

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.

Conditions: Migraine
Being tested: AXS-07 (MoSEIC meloxicam and rizatriptan), Placebo
Keywords: Migraine, AXS-07, Meloxicam, Rizatriptan
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 (MoSEIC meloxicam and rizatriptan)Drug
AXS-07 tablet taken once upon the earliest onset of migraine pain.
PlaceboDrug
Placebo tablet taken once upon the earliest onset of migraine pain.

Study groups in NCT04163185
Study group	Role	What they receive
AXS-07	Experimental	Taken once upon migraine Receives: Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
Placebo	Placebo comparator	Taken once upon migraine Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Achieving Headache Pain Freedom at Hour 2
Absence of headache pain at Hour 2
Measured: Hour 2
Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2
Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2
Measured: Hour 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 201923 Mar 2020

First posted14 Nov 2019
Study start8 Oct 2019
Primary completion16 Mar 2020
Study completion23 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MigraineStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04163185
Sponsor's protocol ID: AXS-07-303
Acronym: INTERCEPT
Status last verified: Jan 2026
First submitted: 12 Nov 2019
Last updated: 28 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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 ID: NCT04163185
Acronym / sponsor ID: INTERCEPT / AXS-07-303
Conditions: Migraine
Keywords: Migraine, AXS-07, Meloxicam, Rizatriptan
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 8 Oct 2019 (actual)
Primary completion: 16 Mar 2020 (actual)
Study completion: 23 Mar 2020 (actual)
First posted: 14 Nov 2019 (actual)
Results: Posted 28 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AXS-07	Experimental	Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)Taken once upon migraine
Placebo	Placebo comparator	Drug: PlaceboTaken once upon migraine

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Has an established diagnosis of migraine with or without aura.

Key exclusion criteria (2 listed)

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.

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 (MoSEIC meloxicam and rizatriptan)AXS-07 tablet taken once upon the earliest onset of migraine pain.	Drug	AXS-07
PlaceboPlacebo tablet taken once upon the earliest onset of migraine pain.	Drug	Placebo

Primary outcome

Percentage of Subjects Achieving Headache Pain Freedom at Hour 2
Time frame: Hour 2
Absence of headache pain at 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

Results and safety

Results posted to the registry on 28 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AXS-07	152	140
Placebo	150	143

Primary outcome: Percentage of Subjects Achieving Headache Pain Freedom at Hour 2

Time frame: Hour 2. Count of participants. Unit: Participants

Measure	AXS-07 n = 132	Placebo n = 135
Value	43	22

AXS-07 vs Placebo: p = 0.002, Chi-squared

Population analysed: ITT Population

Primary outcome: Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2

Time frame: Hour 2. Count of participants. Unit: Participants

Measure	AXS-07 n = 132	Placebo n = 135
Value	58	36

AXS-07 vs Placebo: p = 0.003, Chi-squared

Population analysed: ITT Population

Adverse events

Time frame: Adverse events were collected on or after the dosing date and included any new event or ongoing event that worsened in severity after the date of dosing. Adverse events were collected up to 5 days after the last study visit, up to 12 days per participant.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AXS-07	0 of 140 (0%)	13 of 140 (9.3%)	0 of 140
Placebo	0 of 143 (0%)	5 of 143 (3.5%)	0 of 143

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Axsome WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

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.

41 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 (MoSEIC meloxicam and rizatriptan) in people with Migraine, run by Axsome Therapeutics, Inc. at 41 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 1 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Achieving Headache Pain Freedom at Hour 2 (time frame: Hour 2). 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?

On the ClinicalTrials.gov record for NCT04163185.

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 28 Jan 2026.