Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
NCT ID: NCT03881852
Last Updated: 2023-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2019-01-30
2019-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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AXS-12 (reboxetine)
AXS-12 (Reboxetine)
Dosed orally, twice daily for up to 3 weeks
Placebo
Placebo
Dosed orally, twice daily for up to 3 weeks
Interventions
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AXS-12 (Reboxetine)
Dosed orally, twice daily for up to 3 weeks
Placebo
Dosed orally, twice daily for up to 3 weeks
Eligibility Criteria
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Inclusion Criteria
* Primary diagnosis of narcolepsy with cataplexy
* Willing and able to comply with the study requirements
Exclusion Criteria
* Clinically significant psychiatric disorders
18 Years
70 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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CONCERT Study Site
Birmingham, Alabama, United States
CONCERT Study Site
Alameda, California, United States
CONCERT Study Site
Santa Ana, California, United States
CONCERT Study Site
Boulder, Colorado, United States
CONCERT Study Site
Miami, Florida, United States
CONCERT Study Site
St. Petersburg, Florida, United States
CONCERT Study Site
Gainesville, Georgia, United States
CONCERT Study Site
Fort Wayne, Indiana, United States
CONCERT Study Site
Chevy Chase, Maryland, United States
CONCERT Study Site
The Bronx, New York, United States
CONCERT Study Site
Cincinnati, Ohio, United States
CONCERT Study Site
Columbia, South Carolina, United States
CONCERT Study Site
Austin, Texas, United States
CONCERT Study Site
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol and SAP
Document Type: Statistical Analysis Plan: SAP only
Related Links
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Axsome Therapeutics Website
Other Identifiers
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AXS-12-201
Identifier Type: -
Identifier Source: org_study_id
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