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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 placebo.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-07 | Experimental | Taken once upon migraine |
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| Placebo | Placebo Comparator | Taken once upon migraine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-07 (MoSEIC meloxicam and rizatriptan) | Drug | AXS-07 tablet taken once upon the earliest onset of migraine pain. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Headache Pain Freedom at Hour 2 | Absence of headache pain at Hour 2 | 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 | Hour 2 |
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Key Inclusion Criteria:
• Has an established diagnosis of migraine with or without aura.
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Birmingham | Alabama | 35205 | United States | ||
| Clinical Research Site |
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| Label | URL |
|---|---|
| Axsome Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AXS-07 | Taken once upon the onset of migraine AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 tablet taken once upon the earliest onset of migraine pain. |
| FG001 | Placebo | Taken once upon the onset of migraine Placebo: Placebo tablet taken once upon the earliest onset of migraine pain. |
| 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 | Yes | No | No | Study Protocol | Dec 13, 2019 | Jan 9, 2026 |
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| Placebo | Drug | Placebo tablet taken once upon the earliest onset of migraine pain. |
|
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Clinical Research Site | Mobile | Alabama | 36608 | United States |
| Clinical Research Site | Colton | California | 92399 | 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 | Redlands | California | 92374 | United States |
| Clinical Research Site | Santa Monica | California | 90404 | 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 | 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 | South Miami | Florida | 33143 | United States |
| Clinical Research Site | Sunrise | Florida | 33351 | 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 | Waltham | Massachusetts | 02451 | United States |
| Clinical Research Site | Ann Arbor | Michigan | 48104 | United States |
| Clinical Research Site | Springfield | Missouri | 65810 | United States |
| Clinical Research Site | Albuquerque | New Mexico | 87102 | United States |
| Clinical Research Site | Manlius | New York | 13104 | United States |
| Clinical Research Site | Williamsville | New York | 14221 | United States |
| Clinical Research Site | High Point | North Carolina | 27262 | United States |
| Clinical Research Site | Oklahoma City | Oklahoma | 73106 | 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 | Memphis | Tennessee | 38119 | United States |
| Clinical Research Site | Nashville | Tennessee | 37203 | 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 |
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| Safety Population | The Safety Population included all subjects who received study drug. |
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| ITT Population | The ITT Population consisted of all randomized subjects who had a qualifying migraine. |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | AXS-07 | Taken once upon the onset of migraine AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 tablet taken once upon the earliest onset of migraine pain. |
| BG001 | Placebo | Taken once upon the onset of migraine Placebo: Placebo tablet taken once upon the earliest onset of migraine pain. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Race/Ethnicity, Customized | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Subjects Achieving Headache Pain Freedom at Hour 2 | Absence of headache pain at Hour 2 | ITT Population | Posted | Count of Participants | Participants | Hour 2 |
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| Primary | 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 | ITT Population | Posted | Count of Participants | Participants | Hour 2 |
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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.
Safety Population
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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 | Taken once upon migraine AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 tablet taken once upon the earliest onset of migraine pain. | 0 | 140 | 0 | 140 | 13 | 140 |
| EG001 | Placebo | Taken once upon migraine Placebo: Placebo tablet taken once upon the earliest onset of migraine pain. | 0 | 143 | 0 | 143 | 5 | 143 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Streicher, Executive Director, Clinical Operations | Axsome Therapeutics, Inc. | 212-332-5061 | cstreicher@axsome.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2020 | Jan 9, 2026 | SAP_002.pdf |
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| 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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| ID | Term |
|---|---|
| C093622 | rizatriptan |
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| Male |
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| Asian |
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| Black or African American |
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| White |
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| Multiple |
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