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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881852
Recruitment Status : Completed
First Posted : March 20, 2019
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Study Description
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Brief 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. The study will enroll approximately 20 patients, all of whom will be treated with AXS-12 for three weeks, and with placebo for three weeks. Eligible patients will be randomized to receive either AXS-12 followed by placebo, or placebo followed by AXS-12. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.

Condition or disease Intervention/treatment Phase
Narcolepsy Cataplexy Narcolepsy Excessive Sleepiness Drug: AXS-12 (Reboxetine) Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 30, 2019
Actual Primary Completion Date : November 27, 2019
Actual Study Completion Date : November 27, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AXS-12 (reboxetine) Drug: AXS-12 (Reboxetine)
Dosed orally, twice daily for up to 3 weeks
Placebo Comparator: Placebo Drug: Placebo
Dosed orally, twice daily for up to 3 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Number of cataplexy attacks [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]

Secondary Outcome Measures :
  1. 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.

  2. Maintenance of Wakefulness Test (MWT) [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881852


Locations
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United States, Alabama
CONCERT Study Site
Birmingham, Alabama, United States, 35213
United States, California
CONCERT Study Site
Alameda, California, United States, 94501
CONCERT Study Site
Santa Ana, California, United States, 92705
United States, Colorado
CONCERT Study Site
Boulder, Colorado, United States, 80301
United States, Florida
CONCERT Study Site
Miami, Florida, United States, 33126
CONCERT Study Site
Saint Petersburg, Florida, United States, 33707
United States, Georgia
CONCERT Study Site
Gainesville, Georgia, United States, 30501
United States, Indiana
CONCERT Study Site
Fort Wayne, Indiana, United States, 46804
United States, Maryland
CONCERT Study Site
Chevy Chase, Maryland, United States, 20815
United States, New York
CONCERT Study Site
Bronx, New York, United States, 10467
United States, Ohio
CONCERT Study Site
Cincinnati, Ohio, United States, 45219
United States, South Carolina
CONCERT Study Site
Columbia, South Carolina, United States, 29201
United States, Texas
CONCERT Study Site
Austin, Texas, United States, 78731
CONCERT Study Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Axsome Therapeutics, Inc.
More Information
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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03881852    
Other Study ID Numbers: AXS-12-201
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axsome Therapeutics, Inc.:
CONCERT
AXS-12
EDS
Cataplexy
 Narcolepsy
Axsome
Reboxetine
Additional relevant MeSH terms:
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Narcolepsy
Cataplexy
Sleepiness
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Reboxetine
 Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs