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.

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

sites

The Center for Sleep and Wake Disorders

Chevy Chase, Maryland 20815

Phone: 301-654-1575

from

Chevy Chase, MD