Narcolepsy Clinical Trial
— CONCERTOfficial title:
A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
| Verified date | August 2023 |
| Source | Axsome Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | November 27, 2019 |
| Est. primary completion date | November 27, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Key Inclusion Criteria: - Male or female subjects between 18 and 70 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 |
|---|---|---|---|
| United States | CONCERT Study Site | Alameda | California |
| United States | CONCERT Study Site | Austin | Texas |
| United States | CONCERT Study Site | Birmingham | Alabama |
| United States | CONCERT Study Site | Boulder | Colorado |
| United States | CONCERT Study Site | Bronx | New York |
| United States | CONCERT Study Site | Chevy Chase | Maryland |
| United States | CONCERT Study Site | Cincinnati | Ohio |
| United States | CONCERT Study Site | Columbia | South Carolina |
| United States | CONCERT Study Site | Fort Wayne | Indiana |
| United States | CONCERT Study Site | Gainesville | Georgia |
| United States | CONCERT Study Site | Miami | Florida |
| United States | CONCERT Study Site | Saint Petersburg | Florida |
| United States | CONCERT Study Site | San Antonio | Texas |
| United States | CONCERT Study Site | Santa Ana | California |
| Lead Sponsor | Collaborator |
|---|---|
| Axsome Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks | Presented as LSmeans. A positive change is indicative of improvement. | 2 weeks |
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