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

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

More Details

Status
Completed
Sponsor
Axsome Therapeutics, Inc.

Study Contact