MigrainePhase 3NCT04068051

Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

A Phase 3 study testing AXS-07 in people with Migraine, run by Axsome Therapeutics, Inc. at 51 sites in United States.

Completed

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

Trial summary

MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 706 participants
Where: 51 sitesUnited States
Study dates: 6 Jul 2019to 22 Sep 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 participated in a prior study with AXS-07 for the treatment of migraine

Who cannot join

Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 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, 32516
Clinical Research Site
Birmingham, Alabama, 32542
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
Colton, California, 92324
Clinical Research Site
Columbus, Ohio, 43213
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
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
Los Alamitos, California, 90720
Clinical Research Site
Los Angeles, California, 90017
Clinical Research Site
Los Angeles, California, 90048
Clinical Research Site
Louisville, Kentucky, 40213
Clinical Research Site
Manlius, New York, 13104
Clinical Research Site
Memphis, Tennessee, 38119
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
North Dartmouth, Massachusetts, 02747
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
Phoenix, Arizona, 85004
Clinical Research Site
Portland, Oregon, 97214
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 Diego, California, 92103
Clinical Research Site
Seattle, Washington, 98105
Clinical Research Site
Spring Valley, California, 91978
Clinical Research Site
Springfield, Missouri, 65810
Clinical Research Site
Stockbridge, Georgia, 30281
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: An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC™ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

Read the detailed description

This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.

Conditions: Migraine
Being tested: AXS-07
Keywords: Axsome, AXS-07, MoSEIC™ 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-07Drug
AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.

Study groups in NCT04068051
Study group	Role	What they receive
AXS-07	Experimental	Not described Receives: Drug: AXS-07

What is being measured

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

Long-term Safety of Chronic Intermittent Use of AXS-07
Long-term safety as measured by:
Subjects with any TEAEs
Subjects with suspected to be drug-related TEAEs
Subjects with serious TEAEs
Subjects with TEAEs that led to drug withdrawal
Subjects with TEAEs that led to withdrawal from study
Subjects with TEAEs that resulted in death
Measured: Up to 12 months

Timeline

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

6 Jul 201922 Sep 2020

First posted28 Aug 2019
Study start6 Jul 2019
Primary completion22 Sep 2020
Study completion22 Sep 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.
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: 706 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04068051
Sponsor's protocol ID: AXS-07-302
Status last verified: Sep 2023
First submitted: 27 Jul 2019
Last updated: 10 Oct 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?

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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC™ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
ClinicalTrials.gov ID: NCT04068051
Acronym / sponsor ID: AXS-07-302
Conditions: Migraine
Keywords: Axsome, AXS-07, MoSEIC™ meloxicam, rizatriptan
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 706 participants (actual)
Lead sponsor: Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 6 Jul 2019 (actual)
Primary completion: 22 Sep 2020 (actual)
Study completion: 22 Sep 2020 (actual)
First posted: 28 Aug 2019 (actual)
Results: Posted 10 Oct 2023

Clinical summary

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

Detailed description

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	Experimental	Drug: AXS-07

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 participated in a prior study with AXS-07 for the treatment of migraine

Key exclusion criteria (2 listed)

Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07
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-07AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.	Drug	AXS-07

Primary outcome

Long-term Safety of Chronic Intermittent Use of AXS-07
Time frame: Up to 12 months
Long-term safety as measured by: Subjects with any TEAEs Subjects with suspected to be drug-related TEAEs Subjects with serious TEAEs Subjects with TEAEs that led to drug withdrawal Subjects with TEAEs that led to withdrawal from study Subjects with TEAEs that resulted in death

Results and safety

Results posted to the registry on 10 Oct 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	706	138

Primary outcome: Long-term Safety of Chronic Intermittent Use of AXS-07

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	AXS-07 n = 706
Subjects with any TEAEs	293
Subjects with suspected to be drug-related TEAEs	118
Subjects with serious TEAEs	8
Subjects with TEAEs that led to drug withdrawal	10
Subjects with TEAEs that led to withdrawal from study	13
Subjects with TEAEs that resulted in death	0

Population analysed: Safety Population includes all subjects who received at least one dose of study drug.

Adverse events

Time frame: Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AXS-07	8 of 706 (1.1%)	95 of 706 (13.5%)	0 of 706

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

51 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 in people with Migraine, run by Axsome Therapeutics, Inc. at 51 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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?

Yes. Results are posted in the registry (first posted 10 Oct 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?

Long-term Safety of Chronic Intermittent Use of AXS-07 (time frame: Up to 12 months). 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 NCT04068051.

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 10 Oct 2023.