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NCT05113745 Clinical Trial

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

Narcolepsy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05113745
Other study ID # AXS-12-302
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date October 20, 2021
Est. completion date December 2024

Study information
Verified date January 2024
Source Axsome Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 90
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 15 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-12 (reboxetine)
AXS-12 tablets, taken twice daily
• Placebo
Placebo tablets, taken twice daily

Locations
Country Name City State
Canada Clinical Research Site Toronto Ontario
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Austin Texas
United States Clinical Research Site Boulder Colorado
United States Clinical Research Site Brandon Florida
United States Clinical Research Site Charleston South Carolina
United States Clinical Research Site Chevy Chase Maryland
United States Clinical Research Site Cincinnati Ohio
United States Clinical Research Site Clearwater Florida
United States Clinical Research Site Colorado Springs Colorado
United States Clinical Research Site Columbia South Carolina
United States Clinical Research Site Denver North Carolina
United States Clinical Research Site Doral Florida
United States Clinical Research Site Fort Wayne Indiana
United States Clinical Research Site Gastonia North Carolina
United States Clinical Research Site Huntersville North Carolina
United States Clinical Research Site Kalamazoo Michigan
United States Clinical Research Site Las Vegas Nevada
United States Clinical Research Site Miami Lakes Florida
United States Clinical Research Site Novi Michigan
United States Clinical Research Site Phoenix Arizona
United States Clinical Research Site Saint Louis Missouri
United States Clinical Research Site San Antonio Texas
United States Clinical Research Site Santa Ana California
United States Clinical Research Site Stockbridge Georgia
United States Clinical Research Site West Long Branch New Jersey
United States Clinical Research Site Winter Park Florida
United States Clinical Research Site Wyomissing Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term safety as measured by the incidence of treatment-emergent adverse events Up to 28 weeks
Primary Efficacy as measured by change in frequency of cataplexy attacks from baseline. Baseline to Week 27
See also
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Completed NCT02821715 - Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Phase 2
Completed NCT01681121 - A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy Phase 2
Completed NCT01789398 - Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) Phase 3
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Completed NCT01067235 - Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy Phase 3
Completed NCT00228566 - Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Completed NCT00107796 - Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy Phase 3
Completed NCT00107848 - PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Completed NCT00132873 - Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Recruiting NCT04899947 - Child and Adolescent Registry for Participants With Narcolepsy

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