Migraine Clinical Trial
— MOMENTUMOfficial title:
MOMENTUM: A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
| Verified date | August 2023 |
| Source | Axsome Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 meloxicam, rizatriptan, and placebo for the treatment of a migraine attack. This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.
| Status | Completed |
| Enrollment | 1594 |
| Est. completion date | December 10, 2019 |
| Est. primary completion date | December 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Key Inclusion Criteria: - Has an established diagnosis of migraine with or without aura. - Has experienced an inadequate response to prior acute treatments. Key Exclusion Criteria: - Has previously received any investigational drug or device or investigational therapy within 30 days before Screening. - Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinical Research Site | Albuquerque | New Mexico |
| United States | Clinical Research Site | Ann Arbor | Michigan |
| United States | Clinical Research Site | Atlanta | Georgia |
| United States | Clinical Research Site | Atlanta | Georgia |
| United States | Clinical Research Site | Austin | Texas |
| United States | Clinical Research Site | Bellevue | Washington |
| United States | Clinical Research Site | Berlin | New Jersey |
| United States | Clinical Research Site | Birmingham | Alabama |
| United States | Clinical Research Site | Birmingham | Alabama |
| United States | Clinical Research Site | Boston | Massachusetts |
| United States | Clinical Research Site | Bronx | New York |
| United States | Clinical Research Site | Canoga Park | California |
| United States | Clinical Research Site | Charleston | South Carolina |
| United States | Clinical Research Site | Charlottesville | Virginia |
| United States | Clinical Research Site | Cincinnati | Ohio |
| United States | Clinical Research Site | Clermont | Florida |
| United States | Clinical Research Site | Cleveland | Ohio |
| United States | Clinical Research Site | Colton | California |
| United States | Clinical Research Site | Culver City | California |
| United States | Clinical Research Site | DeLand | Florida |
| United States | Clinical Research Site | Dublin | Ohio |
| United States | Clinical Research Site | Encino | California |
| United States | Clinical Research Site | Endwell | New York |
| United States | Clinical Research Site | Evanston | Illinois |
| United States | Clinical Research Site | Fernandina Beach | Florida |
| United States | Clinical Research Site | Hallandale Beach | Florida |
| United States | Clinical Research Site | Hialeah | Florida |
| United States | Clinical Research Site | High Point | North Carolina |
| United States | Clinical Research Site | Hollywood | Florida |
| United States | Clinical Research Site | Jacksonville | Florida |
| United States | Clinical Research Site | Kansas City | Missouri |
| United States | Clinical Research Site | Knoxville | Tennessee |
| United States | Clinical Research Site | Lake City | Florida |
| United States | Clinical Research Site | Lake Worth | Florida |
| United States | Clinical Research Site | Las Vegas | Nevada |
| United States | Clinical Research Site | Lenexa | Kansas |
| United States | Clinical Research Site | Lexington | Kentucky |
| United States | Clinical Research Site | Little Rock | Arkansas |
| United States | Clinical Research Site | Los Alamitos | California |
| United States | Clinical Research Site | Los Angeles | California |
| United States | Clinical Research Site | Louisville | Kentucky |
| United States | Clinical Research Site | Manlius | New York |
| United States | Clinical Research Site | Memphis | Tennessee |
| United States | Clinical Research Site | Meridian | Idaho |
| United States | Clinical Research Site | Miami | Florida |
| United States | Clinical Research Site | Minneapolis | Minnesota |
| United States | Clinical Research Site | Mobile | Alabama |
| United States | Clinical Research Site | Mount Pleasant | South Carolina |
| United States | Clinical Research Site | Nashville | Tennessee |
| United States | Clinical Research Site | New Orleans | Louisiana |
| United States | Clinical Research Site | New York | New York |
| United States | Clinical Research Site | Norfolk | Virginia |
| United States | Clinical Research Site | North Dartmouth | Massachusetts |
| United States | Clinical Research Site | Oceanside | California |
| United States | Clinical Research Site | Ocoee | Florida |
| United States | Clinical Research Site | Oklahoma City | Oklahoma |
| United States | Clinical Research Site | Orange City | Florida |
| United States | Clinical Research Site | Orlando | Florida |
| United States | Clinical Research Site | Ormond Beach | Florida |
| United States | Clinical Research Site | Philadelphia | Pennsylvania |
| United States | Clinical Research Site | Phoenix | Arizona |
| United States | Clinical Research Site | Pomona | California |
| United States | Clinical Research Site | Portland | Oregon |
| United States | Clinical Research Site | Redlands | California |
| United States | Clinical Research Site | Riverside | California |
| United States | Clinical Research Site | Rochester | New York |
| United States | Clinical Research Site | Salem | Oregon |
| United States | Clinical Research Site | Salt Lake City | Utah |
| United States | Clinical Research Site | San Antonio | Texas |
| United States | Clinical Research Site | San Diego | California |
| United States | Clinical Research Site | Santa Monica | California |
| United States | Clinical Research Site | Seattle | Washington |
| United States | Clinical Research Site | South Miami | Florida |
| United States | Clinical Research Site | Spring Valley | California |
| United States | Clinical Research Site | Springfield | Missouri |
| United States | Clinical Research Site | Stockbridge | Georgia |
| United States | Clinical Research Site | Sunrise | Florida |
| United States | Clinical Research Site | Tampa | Florida |
| United States | Clinical Research Site | Tempe | Arizona |
| United States | Clinical Research Site | Toms River | New Jersey |
| United States | Clinical Research Site | Walnut Creek | California |
| United States | Clinical Research Site | Waterbury | Connecticut |
| United States | Clinical Research Site | Watertown | Massachusetts |
| United States | Clinical Research Site | Williamsville | New York |
| United States | Clinical Research Site | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Axsome Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Subjects Reporting Headache Pain Freedom | Absence of headache pain. AXS-07 vs Placebo. | Hour 2 following dose administration | |
| Primary | Percentage of Subjects With Absence of Most Bothersome Symptom | Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo. | Hour 2 following dose administration |
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