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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
Dosed orally, twice daily for up to 3 weeks
Dosed orally, twice daily for up to 3 weeks
CONCERT Study Site
Birmingham, Alabama, United States
CONCERT Study Site
Alameda, California, United States
CONCERT Study Site
Santa Ana, California, United States
CONCERT Study Site
Boulder, Colorado, United States
CONCERT Study Site
Miami, Florida, United States
CONCERT Study Site
St. Petersburg, Florida, United States
CONCERT Study Site
Gainesville, Georgia, United States
CONCERT Study Site
Fort Wayne, Indiana, United States
CONCERT Study Site
Chevy Chase, Maryland, United States
CONCERT Study Site
The Bronx, New York, United States
...and 4 more locations
Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
Presented as LSmeans. A positive change is indicative of improvement.
Time frame: 2 weeks
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