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

Sex: All

Ages: 18 Years – 70 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 21

Sponsor: Axsome Therapeutics, Inc.

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. 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.

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03881852). StuddyBuddy aggregates publicly available trial information.