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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-07 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-07 | Drug | AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Birmingham | Alabama | 32516 | United States | ||
| Clinical Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | AXS-07 | AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2019 |
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| Birmingham |
| Alabama |
| 32542 |
| United States |
| Clinical Research Site | Mobile | Alabama | 36608 | United States |
| Clinical Research Site | Phoenix | Arizona | 85004 | United States |
| Clinical Research Site | Canoga Park | California | 91303 | United States |
| Clinical Research Site | Colton | California | 92324 | 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 | Los Angeles | California | 90048 | United States |
| Clinical Research Site | San Diego | California | 92103 | 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 | Miami | Florida | 33155 | 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 | 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 | North Dartmouth | Massachusetts | 02747 | United States |
| Clinical Research Site | Waltham | Massachusetts | 02451 | United States |
| Clinical Research Site | Ann Arbor | Michigan | 48104 | United States |
| Clinical Research Site | Minneapolis | Minnesota | 55402 | United States |
| Clinical Research Site | Springfield | Missouri | 65810 | United States |
| Clinical Research Site | Las Vegas | Nevada | 89102 | United States |
| Clinical Research Site | Albuquerque | New Mexico | 87102 | United States |
| Clinical Research Site | Manlius | New York | 13104 | United States |
| Clinical Research Site | Rochester | New York | 14609 | United States |
| Clinical Research Site | Williamsville | New York | 14221 | United States |
| Clinical Research Site | High Point | North Carolina | 27262 | United States |
| Clinical Research Site | Cincinnati | Ohio | 45212 | United States |
| Clinical Research Site | Columbus | Ohio | 43213 | United States |
| Clinical Research Site | Oklahoma City | Oklahoma | 73106 | United States |
| Clinical Research Site | Portland | Oregon | 97214 | United States |
| Clinical Research Site | Salem | Oregon | 97301 | 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 | Knoxville | Tennessee | 37920 | United States |
| Clinical Research Site | Memphis | Tennessee | 38119 | 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 |
| Clinical Research Site | Seattle | Washington | 98105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population includes all subjects who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | AXS-07 | AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Safety Population includes all subjects who received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to 12 months |
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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.
Safety Population includes all subjects who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AXS-07 | AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. | 0 | 706 | 8 | 706 | 95 | 706 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mitral valve incompetence | Cardiac disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA Dictionary | Non-systematic Assessment |
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| Musculoskeletal procedural complication | Injury, poisoning and procedural complications | MedDRA Dicionary | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Victim of crime | Social circumstances | MedDRA Dictionary | Non-systematic Assessment |
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| Skin graft | Surgical and medical procedures | MedDRA Dictionary | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Streicher, Vice President, Clinical Operations | Axsome Therapeutics, Inc. | 212-332-5061 | cstreicher@axsome.com |
| Sep 15, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Subjects with TEAEs that led to drug withdrawal |
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| Subjects with TEAEs that led to withdrawal from study |
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| Subjects with TEAEs that resulted in death |
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