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

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ClinicalTrials.gov Identifier: NCT03881852
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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




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) ]


Information from the National Library of Medicine

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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

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


Contacts
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Contact: Study Director +1 (212) 332-3241 CONCERT@axsome.com

Locations
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United States, Alabama
Sleep Disorders Centers of Alabama Recruiting
Birmingham, Alabama, United States, 35213
Contact: Study Coordinator    205-599-1020 ext 122    wbooth@sleepalabama.com   
United States, California
California Center for Sleep Disorders Recruiting
Alameda, California, United States, 94501
Contact: Study Coordinator    510-263-3331    rmccormick@sleepdx.com   
SDS Clinical Trials Recruiting
Santa Ana, California, United States, 92705
Contact: Study Coordinator    714-834-1565    charlotte@sdsclinicaltrials.com   
United States, Colorado
Alpine Research Center Recruiting
Boulder, Colorado, United States, 80301
Contact: Study Coordinator    303-443-7229    peg@alpineresearch.com   
United States, Florida
Sleep Medicine Specialists of South Florida Recruiting
Miami, Florida, United States, 33126
Contact: Study Coordinator    305-994-1825    malmanzar@southfloridasleeps.com   
Clinical Research Group of St Petersburg Recruiting
Saint Petersburg, Florida, United States, 33707
Contact: Study Coordinator    727-360-0853    mobrien@crgstpete.com   
United States, Georgia
Sleep Disorders Center of Georgia Recruiting
Gainesville, Georgia, United States, 30501
Contact: Study Coordinator    678-961-0733    brianna.rice@georgianeurocenter.com   
United States, Indiana
Fort Wayne Neurological Center Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Study Coordinator    260-436-2416 ext 2143    dkocks@fwnc.com   
United States, Maryland
The Center for Sleep and Wake Disorders Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Study Coordinator    301-654-1575    robert@sleepdoc.com   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Study Coordinator    718-920-2880    mfiguera@montefiore.org   
United States, Ohio
Intrepid Research Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Study Coordinator    513-977-8891    kbartholomew@intrepidresearch.md   
United States, South Carolina
Bogan Sleep Consultants, LLC Recruiting
Columbia, South Carolina, United States, 29201
Contact: Study Coordinator    803-251-3093    Kim.Bowyer@bogansleep.com   
United States, Texas
FutureSearch Trials of Neurology Recruiting
Austin, Texas, United States, 78731
Contact: Study Coordinator    512-380-9925    kevinf@fstrials.com   
Sleep Therapy Research Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-593-4080    rafati.sue@sleeptrc.com   
Sponsors and Collaborators
Axsome Therapeutics, Inc.

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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03881852     History of Changes
Other Study ID Numbers: AXS-12-201
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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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
Signs and Symptoms
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