A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects with Narcolepsy (ENCORE)

Phase 3

Completed

• Conditions: Narcolepsy; Excessive Daytime Sleepiness; Cataplexy
• Interventions: Drug: AXS-12 (reboxetine); Drug: Placebo

• Registration Number: NCT05113745
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief Summary

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Detailed Description

This study is a multi-center trial consisting of a 24-week open-label period, followed by a 4-week double-blind, placebo-controlled, randomized withdrawal period. At the Week 24 visit, subjects will be randomized in a 1:1 ratio either to continue to receive AXS-12 or to switch to placebo, for the next 4 weeks. Eligible subjects will have previously participated in the AXS-12-301 study.

Study Timeline

• Study Start: 2021-10-20
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-09
• Primary Completion: 2024-09-12
• Study Completion: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Completed the treatment period of Study AXS-12-301
• Willing and able to comply with the study requirements

Exclusion Criteria

• Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-12 (reboxetine)	AXS-12 (reboxetine)	* Up to 24 weeks in open-label period * Up to 4 weeks in randomized double-blind period
Placebo	Placebo	Up to 4 weeks in randomized double-blind period

Primary Outcome Measures

Name	Time	Method
Efficacy as measured by change in frequency of cataplexy attacks from baseline.	Baseline to Week 27
Long-term safety as measured by the incidence of treatment-emergent adverse events	Up to 28 weeks

Trial Locations

Locations (1)

Clinical Research Site; 🇨🇦 Toronto, Ontario, Canada