A Phase 2 interventional study of AXS-12 (Reboxetine) and Placebo in Narcolepsy, Cataplexy Narcolepsy and Excessive Sleepiness, sponsored by Axsome Therapeutics, Inc.. Completed at 14 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Axsome Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
31 studies on the registry are indexed under Cataplexy; 5 are open to participants now.
This study's enrollment of 21 is below the median of 117 across 27 interventional studies indexed under Cataplexy.
Browse Cataplexy studies →Axsome Therapeutics, Inc. is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Compared within Cataplexy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Narcolepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: AXS-12 (Reboxetine)
Drug: Placebo
Dosed orally, twice daily for up to 3 weeks
Dosed orally, twice daily for up to 3 weeks
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
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 \[placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks\].
| Milestone | Sequence 1 | Sequence 2 |
|---|---|---|
| Started | 11 | 10 |
| Dosed with axs-12 | 11 | 10 |
| Dosed with placebo | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 1 | 0 |
Presented as LSmeans. A positive change is indicative of improvement.
| weekly cataplexy attacks | AXS-12 (Reboxetine) | Placebo |
|---|---|---|
| Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks | 13.0 ± 3.5 | -0.28 ± 3.5 |
Collected over Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AXS-12 (Reboxetine) | 0/21 (0%) | 0/21 (0%) | 9/21 (42.9%) |
| Placebo | 0/20 (0%) | 0/20 (0%) | 8/20 (40%) |
| Event | AXS-12 (Reboxetine) | Placebo |
|---|---|---|
| AnxietyPsychiatric disorders | 4/21 | 1/20 |
| ConstipationGastrointestinal disorders | 4/21 | 0/20 |
| InsomniaPsychiatric disorders | 4/21 | 1/20 |
| Blood pressure increasedInvestigations | 0/21 | 2/20 |
| NauseaGastrointestinal disorders | 0/21 | 2/20 |
| Dry mouthGastrointestinal disorders | 2/21 | 0/20 |
| DepressionPsychiatric disorders | 1/21 | 1/20 |
| HeadacheNervous system disorders | 1/21 | 1/20 |
| Allergy to animalImmune system disorders | 0/21 | 1/20 |
| DiarrheaGastrointestinal disorders | 0/21 | 1/20 |
Safety Population
| Age, Continuous(years) | Sequence 1 | Sequence 2 | Total |
|---|---|---|---|
| Mean | 32.3 ± 12.44 | 32.9 ± 6.74 | 32.6 ± 9.90 |
| Sex: Female, Male(Participants) | Sequence 1 | Sequence 2 | Total |
|---|---|---|---|
| Female | 10 | 7 | 17 |
| Male | 1 | 3 | 4 |
| Race (NIH/OMB)(Participants) | Sequence 1 | Sequence 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 6 | 8 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Reboxetine