Cataplexy Narcolepsy, Excessive Sleepiness, Narcolepsy
Conditions
Keywords
CONCERT, AXS-12, EDS, Cataplexy, Narcolepsy, Axsome, Reboxetine
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.
Interventions
Dosed orally, twice daily for up to 3 weeks
DRUGPlacebo
Dosed orally, twice daily for up to 3 weeks
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks | 2 weeks | Presented as LSmeans. A positive change is indicative of improvement. |
Countries
United States
Participant flow
Recruitment details
Crossover Design: Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to Sequence 1 \[AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks\] or Sequence 2 \[placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks\].
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1 Sequence 1 - AXS-12 (reboxetine) for three weeks followed by placebo for three weeks | 11 |
| Sequence 2 Sequence 2 - Placebo for three weeks followed by AXS-12 (reboxetine) for three weeks | 10 |
| Total | 21 |
Baseline characteristics
| Characteristic | Sequence 2 | Total | Sequence 1 |
|---|---|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 6.74 | 32.6 years STANDARD_DEVIATION 9.9 | 32.3 years STANDARD_DEVIATION 12.44 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 14 Participants | 6 Participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 9 / 21 | 8 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
Presented as LSmeans. A positive change is indicative of improvement.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AXS-12 (Reboxetine) | Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks | 13.0 weekly cataplexy attacks | Standard Error 3.5 |
| Placebo | Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks | -0.28 weekly cataplexy attacks | Standard Error 3.5 |
p-value: <0.001Mixed Models Analysis