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NCT04072380 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
A Phase 2 study, sponsored by Suven Life Sciences Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 190
- Enrollment target
NCT04072380: Completed Phase 2 study, sponsored by Suven Life Sciences Limited.
NCT04072380 is a Phase 2 study that has completed, run by Suven Life Sciences Limited. The registered enrollment target is 190 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04072380, a Phase 2 study, has completed, sponsored by Suven Life Sciences Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 190 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The Epworth Sleepiness Scale (ESS) is a patient-reported questionnaire consisting of 8 questions. Each of the items are rated on a 4-point scale (0-3), based on the usual chances of dozing off or falling asleep while engaged in eight different activities. The total ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. Higher values represent a worse outcome.
Interventions
- DRUG Placebo
- DRUG SUVN-G3031
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2019-09-21 |
| Est. Completion | 2023-06-13 |
| Phase | Phase 2 |
What the finished NCT04072380 record still lists
NCT04072380 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04072380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04072380 about?
NCT04072380 is a clinical study titled "A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy". 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.
What is the current status of trial NCT04072380?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 190 participants. The study started on 2019-09-21. Estimated completion is 2023-06-13.
What interventions are being tested in trial NCT04072380?
The interventions under investigation include: Placebo (DRUG), SUVN-G3031 (DRUG).
Who is sponsoring clinical trial NCT04072380?
This trial is sponsored by Suven Life Sciences Limited, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04072380's enrollment target sits among peer trials
190 353rd of 2000 higher than 1,646 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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