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NCT03881852 Clinical Trial

Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

Narcolepsy Clinical Trial

— CONCERT  

Official title:
A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03881852
Other study ID # AXS-12-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 30, 2019
Est. completion date November 27, 2019

Study information
Verified date August 2023
Source Axsome Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date November 27, 2019
Est. primary completion date November 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Key Inclusion Criteria: - Male or female subjects between 18 and 70 years of age, inclusive - Primary diagnosis of narcolepsy with cataplexy - Willing and able to comply with the study requirements Exclusion Criteria: - Other clinically significant conditions potentially causing EDS - Clinically significant psychiatric disorders

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-12 (Reboxetine)
Dosed orally, twice daily for up to 3 weeks
• Placebo
Dosed orally, twice daily for up to 3 weeks

Locations
Country Name City State
United States CONCERT Study Site Alameda California
United States CONCERT Study Site Austin Texas
United States CONCERT Study Site Birmingham Alabama
United States CONCERT Study Site Boulder Colorado
United States CONCERT Study Site Bronx New York
United States CONCERT Study Site Chevy Chase Maryland
United States CONCERT Study Site Cincinnati Ohio
United States CONCERT Study Site Columbia South Carolina
United States CONCERT Study Site Fort Wayne Indiana
United States CONCERT Study Site Gainesville Georgia
United States CONCERT Study Site Miami Florida
United States CONCERT Study Site Saint Petersburg Florida
United States CONCERT Study Site San Antonio Texas
United States CONCERT Study Site Santa Ana California

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

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks Presented as LSmeans. A positive change is indicative of improvement. 2 weeks
See also
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Completed NCT02821715 - Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients 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 NCT05059223 - A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy Phase 3
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Completed NCT03173378 - Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Completed NCT05055024 - An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy Phase 2
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 NCT00107848 - PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated 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 NCT00132873 - Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Phase 3
Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'

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