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

NCT ID: NCT05113745

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2024-11-15

Brief Summary

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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

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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.

Conditions

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Narcolepsy Cataplexy Excessive Daytime Sleepiness

Keywords

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AXS-12 Narcolepsy Cataplexy Excessive Daytime Sleepiness Reboxetine Axsome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label treatment period, followed by a double-blind treatment period.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AXS-12 (reboxetine)

* Up to 24 weeks in open-label period
* Up to 4 weeks in randomized double-blind period

Group Type EXPERIMENTAL

AXS-12 (reboxetine)

Intervention Type DRUG

AXS-12 tablets, taken twice daily

Placebo

Up to 4 weeks in randomized double-blind period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets, taken twice daily

Interventions

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AXS-12 (reboxetine)

AXS-12 tablets, taken twice daily

Intervention Type DRUG

Placebo

Placebo tablets, taken twice daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axsome Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Site

Phoenix, Arizona, United States

Site Status

Clinical Research Site

Boulder, Colorado, United States

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Colorado Springs, Colorado, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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Doral, Florida, United States

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Miami Lakes, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Stockbridge, Georgia, United States

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Chevy Chase, Maryland, United States

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Kalamazoo, Michigan, United States

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Novi, Michigan, United States

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Neptune City, New Jersey, United States

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Denver, North Carolina, United States

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Gastonia, North Carolina, United States

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Huntersville, North Carolina, United States

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Cincinnati, Ohio, United States

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Wyomissing, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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San Antonio, Texas, United States

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Clinical Research Site

Toronto, Ontario, Canada

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Countries

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United States Canada

Related Links

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http://www.axsome.com

Axsome Therapeutics Website

Other Identifiers

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AXS-12-302

Identifier Type: -

Identifier Source: org_study_id