Narcolepsy Clinical Trial
— SYMPHONYOfficial title:
A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
| Verified date | April 2024 |
| Source | Axsome Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | March 15, 2024 |
| Est. primary completion date | March 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Male or female subjects between 15 and 75 years of age, inclusive - Primary diagnosis of narcolepsy with cataplexy - Willing and able to comply with the study requirements Exclusion Criteria: - Other clinically significant conditions potentially causing EDS - Clinically significant psychiatric disorders |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Clinical Research Site | Markham | Ontario |
| Canada | Clinical Research Site | Toronto | Ontario |
| Canada | Clinical Research Site | Toronto | Ontario |
| United States | Clinical Research Site | Alabaster | Alabama |
| 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 | Boulder | Colorado |
| United States | Clinical Research Site | Brandon | Florida |
| United States | Clinical Research Site | Brooklyn | New York |
| United States | Clinical Research Site | Charleston | South Carolina |
| United States | Clinical Research Site | Chevy Chase | Maryland |
| United States | Clinical Research Site | Cincinnati | Ohio |
| United States | Clinical Research Site | Clearwater | Florida |
| United States | Clinical Research Site | Colorado Springs | Colorado |
| United States | Clinical Research Site | Columbia | South Carolina |
| United States | Clinical Research Site | Denver | North Carolina |
| United States | Clinical Research Site | Doral | Florida |
| United States | Clinical Research Site | Fort Wayne | Indiana |
| United States | Clinical Research Site | Gainesville | Georgia |
| United States | Clinical Research Site | Gastonia | North Carolina |
| United States | Clinical Research Site | Honolulu | Hawaii |
| United States | Clinical Research Site | Huntersville | North Carolina |
| United States | Clinical Research Site | Kalamazoo | Michigan |
| United States | Clinical Research Site | Kissimmee | Florida |
| United States | Clinical Research Site | Las Vegas | Nevada |
| United States | Clinical Research Site | Macon | Georgia |
| United States | Clinical Research Site | Maplewood | Missouri |
| United States | Clinical Research Site | Miami | Florida |
| United States | Clinical Research Site | Miami Lakes | Florida |
| United States | Clinical Research Site | New Hyde Park | New York |
| United States | Clinical Research Site | Newton | Massachusetts |
| United States | Clinical Research Site | North Dartmouth | Massachusetts |
| United States | Clinical Research Site | Novi | Michigan |
| United States | Clinical Research Site | Peoria | Illinois |
| United States | Clinical Research Site | Peoria | Arizona |
| United States | Clinical Research Site | Phoenix | Arizona |
| United States | Clinical Research Site | Redwood City | California |
| United States | Clinical Research Site | Saint Petersburg | Florida |
| United States | Clinical Research Site | San Antonio | Texas |
| United States | Clinical Research Site | San Diego | California |
| United States | Clinical Research Site | Santa Ana | California |
| United States | Clinical Research Site | Santa Monica | California |
| United States | Clinical Research Site | Stockbridge | Georgia |
| United States | Clinical Research Site | Sugar Land | Texas |
| United States | Clinical Research Site | Tampa | Florida |
| United States | Clinical Research Site | West Long Branch | New Jersey |
| United States | Clinical Research Site | Williamsburg | Virginia |
| United States | Clinical Research Site | Winter Park | Florida |
| United States | Clinical Research Site | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Axsome Therapeutics, Inc. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of cataplexy attacks | Average number of cataplexy attacks per week | Change from Baseline to Week 5 |
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