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NCT03881852 · ClinicalTrials.gov registry record · Phase 2
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
A Phase 2 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03881852: Completed Phase 2 study, sponsored by Axsome Therapeutics.
NCT03881852 is a Phase 2 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03881852, a Phase 2 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
Presented as LSmeans. A positive change is indicative of improvement.
Interventions
- DRUG Placebo
- DRUG AXS-12 (Reboxetine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-04-05 |
| Est. Completion | 2019-11-27 |
| Phase | Phase 2 |
What the finished NCT03881852 record still lists
NCT03881852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03881852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03881852 about?
NCT03881852 is a clinical study titled "Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)". 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 ...
What is the current status of trial NCT03881852?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2019-04-05. Estimated completion is 2019-11-27.
What interventions are being tested in trial NCT03881852?
The interventions under investigation include: Placebo (DRUG), AXS-12 (Reboxetine) (DRUG).
Who is sponsoring clinical trial NCT03881852?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03881852's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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