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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 is a Phase 2 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03881852
The ClinicalTrials.gov registry entry for NCT03881852 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03881852 reports 0 study locations.
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.
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