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This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.
Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-07 (meloxicam-rizatriptan) | Experimental | Up to 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-07 (meloxicam-rizatriptan) | Drug | AXS-07 tablets, taken orally for the acute treatment of migraine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with headache pain relief | Absence of headache pain and without the use of rescue medication. | Hour 2 following dose administration |
| Percentage of subjects with absence of the Most Bothersome Symptom | Absence of the most bothersome symptom, defined at the onset of migraine. | Hour 2 following dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Colton | California | 92324 | United States | ||
| Clinical Research Site |
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| Label | URL |
|---|---|
| Axsome Therapeutics Website | View source |
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| Fullerton |
| California |
| 92835 |
| United States |
| Clinical Research Site | La Jolla | California | 92037 | United States |
| Clinical Research Site | Los Angeles | California | 90067 | United States |
| Clinical Research Site | Sherman Oaks | California | 91403 | United States |
| Clinical Research Site | Stamford | Connecticut | 06905 | United States |
| Clinical Research Site | DeLand | Florida | 32720 | United States |
| Clinical Research Site | Hallandale | Florida | 33009 | United States |
| Clinical Research Site | Hollywood | Florida | 33024 | United States |
| Clinical Research Site | Miami | Florida | 33126 | United States |
| Clinical Research Site | Ormond Beach | Florida | 31274 | United States |
| Clinical Research Site | Oviedo | Florida | 32765 | United States |
| Clinical Research Site | Pensacola | Florida | 32504 | United States |
| Clinical Research Site | Winter Park | Florida | 32789 | United States |
| Clinical Research Site | Stockbridge | Georgia | 30281 | United States |
| Clinical Research Site | Avon | Indiana | 46123 | United States |
| Clinical Research Site | Boston | Massachusetts | 02131 | United States |
| Clinical Research Site | North Dartmouth | Massachusetts | 02747 | United States |
| Clinical Research Site | Las Vegas | Nevada | 89102 | United States |
| Clinical Research Site | Albuquerque | New Mexico | 87102 | United States |
| Clinical Research Site | The Bronx | New York | 10466 | United States |
| Clinical Research Site | Williamsville | New York | 14221 | United States |
| Clinical Research Site | Philadelphia | Pennsylvania | 19114 | United States |
| Clinical Research Site | Charleston | South Carolina | 29406 | United States |
| Clinical Research Site | Knoxville | Tennessee | 37909 | United States |
| Clinical Research Site | Nashville | Tennessee | 37203 | United States |
| Clinical Research Site | Cypress | Texas | 77429 | United States |
| Clinical Research Site | Sugar Land | Texas | 77478 | United States |
| Clinical Research Site | Salt Lake City | Utah | 84107 | United States |
| Clinical Research Site | Charlottesville | Virginia | 22911 | United States |
| Clinical Research Site | McLean | Virginia | 22101 | United States |
| 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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