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

Sponsor

Axsome Therapeutics, Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05113745

Collaborator

(none)

Enrollment

Locations

Arms

25.4

Anticipated Duration (Months)

6.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Narcolepsy Cataplexy Excessive Daytime Sleepiness	Drug: AXS-12 (reboxetine) Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy

Actual Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AXS-12 (reboxetine) Up to 24 weeks in open-label period Up to 4 weeks in randomized double-blind period	Drug: AXS-12 (reboxetine) AXS-12 tablets, taken twice daily
Placebo Comparator: Placebo Up to 4 weeks in randomized double-blind period	Drug: Placebo Placebo tablets, taken twice daily

Arm

Intervention/Treatment

Experimental: AXS-12 (reboxetine)

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

Drug: AXS-12 (reboxetine)

AXS-12 tablets, taken twice daily

Placebo Comparator: Placebo

Up to 4 weeks in randomized double-blind period

Drug: Placebo

Placebo tablets, taken twice daily

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Site	Santa Ana	California	United States	92705
2	Clinical Research Site	Colorado Springs	Colorado	United States	80918
3	Clinical Research Site	Clearwater	Florida	United States	33765
4	Clinical Research Site	Atlanta	Georgia	United States	30315
5	Clinical Research Site	Atlanta	Georgia	United States	30328
6	Clinical Research Site	Stockbridge	Georgia	United States	30281
7	Clinical Research Site	Chevy Chase	Maryland	United States	20815
8	Clinical Research Site	Kalamazoo	Michigan	United States	49008
9	Clinical Research Site	Denver	North Carolina	United States	28037
10	Clinical Research Site	Gastonia	North Carolina	United States	28054
11	Clinical Research Site	Cincinnati	Ohio	United States	45245
12	Clinical Research Site	Austin	Texas	United States	78731
13	Clinical Research Site	Toronto	Ontario	Canada	M5S 3A3