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

• Status: Completed
• Trial end date: 2019-11-27
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.
• Treatments: Reboxetine

Criteria

Key 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