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. The study will enroll approximately 20 patients, all of whom will be treated with AXS-12 for three weeks, and with placebo for three weeks. Eligible patients will be randomized to receive either AXS-12 followed by placebo, or placebo followed by AXS-12. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.

Conditions

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

ArmDescriptionAssigned 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

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Study Coordinator
718-920-2880
mfiguera@montefiore.org

More Details

NCT ID
NCT03881852
Status
Recruiting
Sponsor
Axsome Therapeutics, Inc.

Study Contact

Study Director
+1 (212) 332-3241
CONCERT@axsome.com

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.