Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) (CONCERT)
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ClinicalTrials.gov Identifier: NCT03881852 |
Recruitment Status :
Completed
First Posted : March 20, 2019
Results First Posted : August 24, 2023
Last Update Posted : August 24, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Narcolepsy Cataplexy Narcolepsy Excessive Sleepiness | Drug: AXS-12 (Reboxetine) Drug: Placebo | Phase 2 |
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 |
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 |
- 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.
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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 |
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
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
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 |
Documents provided by Axsome Therapeutics, Inc.:
Responsible Party: | Axsome Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03881852 |
Other Study ID Numbers: |
AXS-12-201 |
First Posted: | March 20, 2019 Key Record Dates |
Results First Posted: | August 24, 2023 |
Last Update Posted: | August 24, 2023 |
Last Verified: | August 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CONCERT AXS-12 EDS Cataplexy |
Narcolepsy Axsome Reboxetine |
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 |