MigrainePhase 3MOMENTUMNCT03896009

Maximizing Outcomes in Treating Acute Migraine

A Phase 3 study testing AXS-07 (MoSEIC meloxicam and rizatriptan), Meloxicam and Rizatriptan in people with Migraine, run by Axsome Therapeutics, Inc. at 85 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

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), Meloxicam and Rizatriptan
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,594 participants
Where: 85 sitesUnited States
Study dates: 4 Mar 2019to 10 Dec 2019
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.
Has experienced an inadequate response to prior acute treatments.

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

85 sites in 1 country.

City, postcode or hospital

85 sites in 1 country

United States85 sites

Clinical Research Site
Albuquerque, New Mexico, 87102
Clinical Research Site
Ann Arbor, Michigan, 48104
Clinical Research Site
Atlanta, Georgia, 30312
Clinical Research Site
Atlanta, Georgia, 30331
Clinical Research Site
Austin, Texas, 78731
Clinical Research Site
Bellevue, Washington, 98007
Clinical Research Site
Berlin, New Jersey, 08009
Clinical Research Site
Birmingham, Alabama, 35205
Clinical Research Site
Birmingham, Alabama, 35216
Clinical Research Site
Boston, Massachusetts, 02131
Clinical Research Site
Canoga Park, California, 91303
Clinical Research Site
Charleston, South Carolina, 29406
Clinical Research Site
Charlottesville, Virginia, 22911
Clinical Research Site
Cincinnati, Ohio, 45212
Clinical Research Site
Clermont, Florida, 34711
Clinical Research Site
Cleveland, Ohio, 44122
Clinical Research Site
Colton, California, 92399
Clinical Research Site
Culver City, California, 90230
Clinical Research Site
DeLand, Florida, 32720
Clinical Research Site
Dublin, Ohio, 43016
Clinical Research Site
Encino, California, 91316
Clinical Research Site
Endwell, New York, 12760
Clinical Research Site
Evanston, Illinois, 60201
Clinical Research Site
Fernandina Beach, Florida, 32034
Clinical Research Site
Hallandale, Florida, 33009
Clinical Research Site
Hialeah, Florida, 33012
Clinical Research Site
High Point, North Carolina, 27262
Clinical Research Site
Hollywood, Florida, 33024
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Kansas City, Missouri, 64114
Clinical Research Site
Knoxville, Tennessee, 37920
Clinical Research Site
Lake City, Florida, 32055
Clinical Research Site
Lake Worth, Florida, 33467
Clinical Research Site
Las Vegas, Nevada, 89102
Clinical Research Site
Lenexa, Kansas, 66214
Clinical Research Site
Lexington, Kentucky, 40509
Clinical Research Site
Little Rock, Arkansas, 72209
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
Meridian, Idaho, 83642
Clinical Research Site
Miami, Florida, 33155
Clinical Research Site
Minneapolis, Minnesota, 55402
Clinical Research Site
Mobile, Alabama, 36608
Clinical Research Site
Mt. Pleasant, South Carolina, 29464
Clinical Research Site
Nashville, Tennessee, 37203
Clinical Research Site
New Orleans, Louisiana, 70125
Clinical Research Site
New York, New York, 10017
Clinical Research Site
Norfolk, Virginia, 23507
Clinical Research Site
North Dartmouth, Massachusetts, 02747
Clinical Research Site
Oceanside, California, 92506
Clinical Research Site
Ocoee, Florida, 34761
Clinical Research Site
Oklahoma City, Oklahoma, 73106
Clinical Research Site
Orange City, Florida, 32763
Clinical Research Site
Orlando, Florida, 32801
Clinical Research Site
Ormond Beach, Florida, 32174
Clinical Research Site
Philadelphia, Pennsylvania, 19114
Clinical Research Site
Phoenix, Arizona, 85004
Clinical Research Site
Pomona, California, 91767
Clinical Research Site
Portland, Oregon, 97214
Clinical Research Site
Redlands, California, 92374
Clinical Research Site
Riverside, California, 92503
Clinical Research Site
Rochester, New York, 14609
Clinical Research Site
Salem, Oregon, 97301
Clinical Research Site
Salt Lake City, Utah, 84107
Clinical Research Site
San Antonio, Texas, 78229
Clinical Research Site
San Diego, California, 92103
Clinical Research Site
Santa Monica, California, 90404
Clinical Research Site
Seattle, Washington, 98105
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
Tempe, Arizona, 85283
Clinical Research Site
The Bronx, New York, 10461
Clinical Research Site
Toms River, New Jersey, 08755
Clinical Research Site
Walnut Creek, California, 94598
Clinical Research Site
Waterbury, Connecticut, 06708
Clinical Research Site
Watertown, Massachusetts, 02472
Clinical Research Site
Williamsville, New York, 14221
Clinical Research Site
Wilmington, North Carolina, 24801

Other trials in United States

About this study

Official title: MOMENTUM: 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 meloxicam, rizatriptan, and placebo for the treatment of a migraine attack.

This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.

Conditions: Migraine
Being tested: AXS-07 (MoSEIC meloxicam and rizatriptan), Meloxicam, Rizatriptan, Placebo
Keywords: Migraine, AXS-07, Meloxicam, Rizatriptan, Axsome, Axsome Therapeutics, MoSEIC meloxicam
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 taken once upon onset of a qualifying migraine.
MeloxicamDrug
Meloxicam taken once upon onset of a qualifying migraine.
RizatriptanDrug
Rizatriptan taken once upon onset of a qualifying migraine.
PlaceboDrug
Placebo taken once upon onset of a qualifying migraine.

Study groups in NCT03896009
Study group	Role	What they receive
AXS-07	Experimental	Taken once upon a qualifying migraine Receives: Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
Meloxicam	Active comparator	Taken once upon a qualifying migraine Receives: Drug: Meloxicam
Rizatriptan	Active comparator	Taken once upon a qualifying migraine Receives: Drug: Rizatriptan
Placebo	Placebo comparator	Taken once upon a qualifying migraine Receives: Drug: Placebo

What is being measured

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

Percentage of Subjects Reporting Headache Pain Freedom
Absence of headache pain. AXS-07 vs Placebo.
Measured: Hour 2 following dose administration
Percentage of Subjects With Absence of Most Bothersome Symptom
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.
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.

4 Mar 201910 Dec 2019

First posted29 Mar 2019
Study start4 Mar 2019
Primary completion10 Dec 2019
Study completion10 Dec 2019

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: 1,594 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03896009
Sponsor's protocol ID: AXS-07-301
Acronym: MOMENTUM
Status last verified: Aug 2023
First submitted: 15 Mar 2019
Last updated: 24 Aug 2023
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?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MOMENTUM: 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: NCT03896009
Acronym / sponsor ID: MOMENTUM / AXS-07-301
Conditions: Migraine
Keywords: Migraine, AXS-07, Meloxicam, Rizatriptan, Axsome, Axsome Therapeutics, MoSEIC meloxicam
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,594 participants (actual)
Lead sponsor: Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 4 Mar 2019 (actual)
Primary completion: 10 Dec 2019 (actual)
Study completion: 10 Dec 2019 (actual)
First posted: 29 Mar 2019 (actual)
Results: Posted 24 Aug 2023

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: 4

Arm	Type	Receives
AXS-07	Experimental	Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)Taken once upon a qualifying migraine
Meloxicam	Active comparator	Drug: MeloxicamTaken once upon a qualifying migraine
Rizatriptan	Active comparator	Drug: RizatriptanTaken once upon a qualifying migraine
Placebo	Placebo comparator	Drug: PlaceboTaken once upon a qualifying migraine

Who may qualify

Ages: 18 to 65 years
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 prior acute treatments.

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 taken once upon onset of a qualifying migraine.	Drug	AXS-07
MeloxicamMeloxicam taken once upon onset of a qualifying migraine.	Drug	Meloxicam
RizatriptanRizatriptan taken once upon onset of a qualifying migraine.	Drug	Rizatriptan
PlaceboPlacebo taken once upon onset of a qualifying migraine.	Drug	Placebo

Primary outcome

Percentage of Subjects Reporting Headache Pain Freedom
Time frame: Hour 2 following dose administration
Absence of headache pain. AXS-07 vs Placebo.
Percentage of Subjects With Absence of Most Bothersome Symptom
Time frame: Hour 2 following dose administration
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.

Results and safety

Results posted to the registry on 24 Aug 2023, 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	456	441
Meloxicam	455	433
Rizatriptan	456	434
Placebo	227	218

Primary outcome: Percentage of Subjects Reporting Headache Pain Freedom

Time frame: Hour 2 following dose administration. Count of participants. Unit: Participants

Measure	AXS-07 n = 428	Placebo n = 209
Value	85	14

AXS-07 vs Placebo: p <0.001, Chi-squared

Population analysed: ITT population consists of all randomized subjects who received study drug and had a qualifying migraine.

Primary outcome: Percentage of Subjects With Absence of Most Bothersome Symptom

Time frame: Hour 2 following dose administration. Count of participants. Unit: Participants

Measure	AXS-07 n = 428	Placebo n = 209
Value	158	51

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

Population analysed: ITT population consists of all randomized subjects who received study drug and had a qualifying migraine.

Adverse events

Time frame: Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AXS-07	1 of 441 (0.2%)	49 of 441 (11.1%)	0 of 441
Meloxicam	0 of 433 (0%)	50 of 433 (11.5%)	0 of 433
Rizatriptan	0 of 434 (0%)	67 of 434 (15.4%)	0 of 434
Placebo	0 of 218 (0%)	13 of 218 (6%)	0 of 218

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

85 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), Meloxicam and Rizatriptan in people with Migraine, run by Axsome Therapeutics, Inc. at 85 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 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 24 Aug 2023). 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 Reporting Headache Pain Freedom (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?

On the ClinicalTrials.gov record for NCT03896009.

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 24 Aug 2023.