Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Phase 2
Completed
- Conditions
- Excessive SleepinessNarcolepsyCataplexy Narcolepsy
- Interventions
- Drug: PlaceboDrug: AXS-12 (Reboxetine)
- Registration Number
- NCT03881852
- Lead Sponsor
- Axsome Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo - AXS-12 (reboxetine) AXS-12 (Reboxetine) -
- Primary Outcome Measures
Name Time Method Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks 2 weeks Presented as LSmeans. A positive change is indicative of improvement.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CONCERT Study Site
🇺🇸San Antonio, Texas, United States