Migraine Clinical Trial
Official title:
An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Has an established diagnosis of migraine with or without aura - Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine Exclusion Criteria: - Pregnant, breastfeeding, or planning to become pregnant during the study - Has previously received any investigational drug or device or investigational therapy within 30 days before Screening |
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinical Research Site | Albuquerque | New Mexico |
| United States | Clinical Research Site | Avon | Indiana |
| United States | Clinical Research Site | Boston | Massachusetts |
| United States | Clinical Research Site | Bronx | New York |
| United States | Clinical Research Site | Charleston | South Carolina |
| United States | Clinical Research Site | Charlottesville | Virginia |
| United States | Clinical Research Site | Colton | California |
| United States | Clinical Research Site | Coral Gables | Florida |
| United States | Clinical Research Site | Cypress | Texas |
| United States | Clinical Research Site | DeLand | Florida |
| United States | Clinical Research Site | Fullerton | California |
| United States | Clinical Research Site | Hallandale Beach | Florida |
| United States | Clinical Research Site | High Point | North Carolina |
| United States | Clinical Research Site | Knoxville | Tennessee |
| United States | Clinical Research Site | La Jolla | California |
| United States | Clinical Research Site | Las Vegas | Nevada |
| United States | Clinical Research Site | Los Angeles | California |
| United States | Clinical Research Site | McLean | Virginia |
| United States | Clinical Research Site | Nashville | Tennessee |
| United States | Clinical Research Site | North Dartmouth | Massachusetts |
| United States | Clinical Research Site | Ormond Beach | Florida |
| United States | Clinical Research Site | Oviedo | Florida |
| United States | Clinical Research Site | Pensacola | Florida |
| United States | Clinical Research Site | Philadelphia | Pennsylvania |
| United States | Clinical Research Site | Salt Lake City | Utah |
| United States | Clinical Research Site | Sherman Oaks | California |
| United States | Clinical Research Site | Stamford | Connecticut |
| United States | Clinical Research Site | Stockbridge | Georgia |
| United States | Clinical Research Site | Sugar Land | Texas |
| United States | Clinical Research Site | Sunrise | Florida |
| United States | Clinical Research Site | Williamsville | New York |
| United States | Clinical Research Site | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Axsome Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of subjects with headache pain relief | Absence of headache pain and without the use of rescue medication. | Hour 2 following dose administration | |
| Primary | 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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