CompletedPhase 3

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

United States68 participantsStarted 2021-10-20

Plain-language summary

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

Who can participate

Age range15 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Long-term safety as measured by the incidence of treatment-emergent adverse events

Timeframe: Up to 28 weeks

Efficacy as measured by change in frequency of cataplexy attacks from baseline.

Timeframe: Baseline to Week 27

Trial details

NCT IDNCT05113745

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-15

View on ClinicalTrials.gov More Narcolepsy trials