Einstein Montefiore

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

Purpose

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.

Conditions

Narcolepsy
Cataplexy Narcolepsy
Excessive Sleepiness

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental AXS-12 (reboxetine)		Drug: AXS-12 (Reboxetine) Dosed orally, twice daily for up to 3 weeks
Placebo Comparator Placebo		Drug: Placebo Dosed orally, twice daily for up to 3 weeks

More Details

Status: Completed
Sponsor: Axsome Therapeutics, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.