Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Public ClinicalTrials.gov record NCT03881852. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03881852
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 5, 2019 (Actual)
- Primary completion
- Nov 27, 2019 (Actual)
- Completion
- Nov 27, 2019 (Actual)
- Last update posted
- Jun 15, 2026
2019
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CONCERT Study Site | Birmingham | Alabama | 35213 | — |
| CONCERT Study Site | Alameda | California | 94501 | — |
| CONCERT Study Site | Santa Ana | California | 92705 | — |
| CONCERT Study Site | Boulder | Colorado | 80301 | — |
| CONCERT Study Site | Miami | Florida | 33126 | — |
| CONCERT Study Site | Gainesville | Georgia | 30501 | — |
| CONCERT Study Site | Stockbridge | Georgia | 30281 | — |
| CONCERT Study Site | Fort Wayne | Indiana | 46804 | — |
| CONCERT Study Site | Chevy Chase | Maryland | 20815 | — |
| CONCERT Study Site | The Bronx | New York | 10467 | — |
| CONCERT Study Site | Cincinnati | Ohio | 45219 | — |
| CONCERT Study Site | Columbia | South Carolina | 29201 | — |
| CONCERT Study Site | Austin | Texas | 78731 | — |
| CONCERT Study Site | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03881852, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2026 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03881852 live on ClinicalTrials.gov.