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

Axsome Therapeutics

Status and phase: Completed; Phase 2

Conditions: Cataplexy Narcolepsy; Excessive Sleepiness; Narcolepsy

Treatments: Drug: Placebo; Drug: AXS-12 (Reboxetine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03881852

AXS-12-201

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

21 participants in 2 patient groups, including a placebo group

AXS-12 (reboxetine)

Experimental group

Treatment:

Drug: AXS-12 (Reboxetine)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo