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 |
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.
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
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3550 Jerome Avenue
Bronx, New York 10467
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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