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

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.

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Key information

Conditions

Narcolepsy Cataplexy Cataplexy Narcolepsy Disorders of Excessive Somnolence Dyssomnias Excessive Sleepiness Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CONCERT Study Site, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AXS-12 (reboxetine)

Drug

Dosed orally, twice daily for up to 3 weeks

Placebo

Drug

Dosed orally, twice daily for up to 3 weeks

Primary outcomes

Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks

Time frame: 2 weeks

Presented as LSmeans. A positive change is indicative of improvement.

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: CONCERT

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Mar 20, 2019
Registry last updated: Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed