A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
Public ClinicalTrials.gov record NCT04072380. 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 Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients With Narcolepsy With and Without Cataplexy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.
Study identification
- NCT ID
- NCT04072380
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 190 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 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
- Sep 21, 2019 (Actual)
- Primary completion
- Jun 7, 2023 (Actual)
- Completion
- Jun 13, 2023 (Actual)
- Last update posted
- Jan 13, 2025
2019 – 2023
United States locations
- U.S. sites
- 39
- U.S. states
- 13
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sleep Disorders Center o f Alabama | Birmingham | Alabama | 35213 | — |
| Santa Monica Clinical Trials | Los Angeles | California | 90025 | — |
| Southern California Institute for Respiratory Diseases, Inc. | Los Angeles | California | 90048-6138 | — |
| Pacific Research Network, Inc. | San Diego | California | 92103 | — |
| SDS Clinical Trials Inc. | Santa Ana | California | 92705 | — |
| Meris Clinical Research | Brandon | Florida | 33511 | — |
| Teradan Clinical Trials | Brandon | Florida | 33511 | — |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | — |
| PDS Research | Kissimmee | Florida | 34741 | — |
| Sleep Medicine Specialists of South Florida, PA | Miami | Florida | 33126 | — |
| Ivetmar Medical Group, LLC | Miami | Florida | 33155 | — |
| Florida Pediatric Research Institute | Winter Park | Florida | 32789 | — |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | — |
| NeuroTrials Research Inc | Atlanta | Georgia | 30342 | — |
| The Neuro Center | Gainesville | Georgia | 30501 | — |
| IACT Health | Lawrenceville | Georgia | 30045 | — |
| Sleep Practitioners, LLC | Macon | Georgia | 31210 | — |
| IACT Health | Rincon | Georgia | 31326 | — |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | — |
| Helene A. Emsellem, MD PC | Chevy Chase | Maryland | 20815 | — |
| Bronson Sleep Health | Portage | Michigan | 49024 | — |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | — |
| St Lukes Hospital, Sleep Medicine & Research Center | Chesterfield | Missouri | 63017 | — |
| Clayton Sleep Institute | St Louis | Missouri | 63123 | — |
| Research Carolina Elite | Denver | North Carolina | 28078 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | — |
| Ohio Sleep Medicine Institute | Canton | Ohio | 44718 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | — |
| Intrepid Research, LLC | Cincinnati | Ohio | 45245 | — |
| Cleveland Clinic, Sleep Disorders Center | Cleveland | Ohio | 44195 | — |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | — |
| Respiratory Specialists | Wyomissing | Pennsylvania | 19610 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | — |
| Lowcountry Lung Critical Care | North Charleston | South Carolina | 29406 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | — |
| Roadrunner Research | San Antonio | Texas | 78249 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04072380, 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 Jan 13, 2025 · 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 NCT04072380 live on ClinicalTrials.gov.