Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
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.
Timeline
- Start
- 2019-04-05
- Primary completion
- 2019-11-27
- Completion
- 2019-11-27
Outcome
Met primary endpoint
registry analysis (superiority test); AXS-12 (Reboxetine) vs Placebo; p <0.001; Mixed Models Analysis; note: P-value calculated from LSMean NCT03881852 ↗
release “AXS-12 met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo” gcs-web.com ↗
release “AXS-12 met the primary endpoint demonstrating a highly statistically significant reduction from baseline in the mean weekly number of cataplexy attacks” gcs-web.com ↗
release “AXS-12 has previously met the primary endpoints and demonstrated positive and statistically significant results in the completed SYMPHONY Phase 3 and CONCERT Phase 2 trials” gcs-web.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AXS-12 | Unknown | 10 mg | Oral |