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. 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.
Brief Title
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Narcolepsy
Cataplexy Narcolepsy
Excessive Sleepiness
Eligibility 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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
CONCERT
AXS-12
EDS
Cataplexy
Narcolepsy
Axsome
Reboxetine
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT03881852
Org Class
Industry
Org Full Name
Axsome Therapeutics, Inc.
Org Study Id
AXS-12-201
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Presented as LSmeans. A positive change is indicative of improvement.
Outcome Measure
Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
Outcome Time Frame
2 weeks
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michael Thorpy
Investigator Email
michael.thorpy@einsteinmed.org
Investigator Phone
718-920-4841