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

Completed · Phase 2 · Has a placebo group

Conditions studied: Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness

In brief

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.

Key facts

Study ID

NCT03881852

Run by

Axsome Therapeutics, Inc.

People needed

21

Starts

2019-04-05

Expected to finish

2019-11-27

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Other clinically significant conditions potentially causing EDS
• Clinically significant psychiatric disorders

Where it is running

• CONCERT Study Site — Birmingham, Alabama, United States
• CONCERT Study Site — Alameda, California, United States
• CONCERT Study Site — Santa Ana, California, United States
• CONCERT Study Site — Boulder, Colorado, United States
• CONCERT Study Site — Miami, Florida, United States
• CONCERT Study Site — Gainesville, Georgia, United States
• CONCERT Study Site — Stockbridge, Georgia, United States
• CONCERT Study Site — Fort Wayne, Indiana, United States
• CONCERT Study Site — Chevy Chase, Maryland, United States
• CONCERT Study Site — The Bronx, New York, United States
• CONCERT Study Site — Cincinnati, Ohio, United States
• CONCERT Study Site — Columbia, South Carolina, United States
• CONCERT Study Site — Austin, Texas, United States
• CONCERT Study Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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