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

August 22, 2023 updated by: Axsome Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • CONCERT Study Site
    • California
      • Alameda, California, United States, 94501
        • CONCERT Study Site
      • Santa Ana, California, United States, 92705
        • CONCERT Study Site
    • Colorado
      • Boulder, Colorado, United States, 80301
        • CONCERT Study Site
    • Florida
      • Miami, Florida, United States, 33126
        • CONCERT Study Site
      • Saint Petersburg, Florida, United States, 33707
        • CONCERT Study Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • CONCERT Study Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • CONCERT Study Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • CONCERT Study Site
    • New York
      • Bronx, New York, United States, 10467
        • CONCERT Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • CONCERT Study Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • CONCERT Study Site
    • Texas
      • Austin, Texas, United States, 78731
        • CONCERT Study Site
      • San Antonio, Texas, United States, 78229
        • CONCERT Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Dosed orally, twice daily for up to 3 weeks
Experimental: AXS-12 (reboxetine)
Drug: AXS-12 (Reboxetine)
Dosed orally, twice daily for up to 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
Time Frame: 2 weeks
Presented as LSmeans. A positive change is indicative of improvement.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale (ESS)
Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2)
The ESS is a patient-reported questionnaire consisting 8 questions. Each of the items are rated on a 4-point scale (0-3), based on the usual chances of dozing off or falling asleep while engaged in eight different activities. The total ESS score can range from 0 to 24.
Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2)
Maintenance of Wakefulness Test (MWT)
Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2)
Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2019

Primary Completion (Actual)

November 27, 2019

Study Completion (Actual)

November 27, 2019

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-12-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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