Phase 2 N=21 Randomized Triple-blind Treatment

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

Narcolepsy · Cataplexy Narcolepsy · Excessive Sleepiness

Bottom Line

View on ClinicalTrials.gov: NCT03881852 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks — 13.0; -0.28 weekly cataplexy attacks — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AXS-12 (Reboxetine) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Axsome Therapeutics, Inc.
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks	13.0; -0.28	<0.001 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03881852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.