Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:3/30/2019
Start Date:January 30, 2019
End Date:June 2019
Contact:Study Director
Email:CONCERT@axsome.com
Phone:+1 (212) 332-3241

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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

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. The study will enroll approximately 20 patients,
all of whom will be treated with AXS-12 for three weeks, and with placebo for three weeks.
Eligible patients will be randomized to receive either AXS-12 followed by placebo, or placebo
followed by AXS-12. Efficacy assessments will include the frequency of cataplexy attacks, and
measures of other symptoms of narcolepsy.


Key Inclusion Criteria:

- Male or female subjects between 18 and 65 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
We found this trial at
8
sites
Saint Petersburg, Florida 33707
Phone: 727-360-0853
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Phone: 718-920-2880
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Alameda, California 94501
Phone: 510-263-3331
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Austin, Texas 78703
Phone: 512-380-9925
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Chevy Chase, Maryland 20815
Phone: 301-654-1575
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Cincinnati, Ohio 45245
Phone: 513-977-8891
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1333 Taylor Street
Columbia, South Carolina 29201
Phone: 803-251-3093
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Miami, Florida 33126
Phone: 305-994-1825
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Miami, FL
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