Migraine Clinical Trial
Official title:
An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC™ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
| Verified date | September 2023 |
| Source | Axsome Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 706 |
| Est. completion date | September 22, 2020 |
| Est. primary completion date | September 22, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Has participated in a prior study with AXS-07 for the treatment of migraine Exclusion Criteria: - Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07 - 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 | Austin | Texas |
| 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 | 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 | Colton | California |
| United States | Clinical Research Site | Columbus | Ohio |
| United States | Clinical Research Site | Encino | California |
| United States | Clinical Research Site | Evanston | Illinois |
| United States | Clinical Research Site | Hallandale Beach | Florida |
| United States | Clinical Research Site | High Point | North Carolina |
| United States | Clinical Research Site | Jacksonville | Florida |
| 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 | Los Alamitos | California |
| United States | Clinical Research Site | Los Angeles | 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 | 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 | North Dartmouth | Massachusetts |
| United States | Clinical Research Site | Ocoee | Florida |
| United States | Clinical Research Site | Oklahoma City | Oklahoma |
| 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 | Portland | Oregon |
| 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 Diego | California |
| United States | Clinical Research Site | Seattle | Washington |
| 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 | Tampa | Florida |
| United States | Clinical Research Site | Walnut Creek | California |
| United States | Clinical Research Site | Waltham | Massachusetts |
| United States | Clinical Research Site | Williamsville | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Axsome Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 |
Up to 12 months |
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