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NCT05701774 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
A Phase 3 study of Prader-Willi Syndrome, sponsored by Soleno Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
- 20
- Study locations
NCT05701774: Active Phase 3 study of Prader-Willi Syndrome, sponsored by Soleno Therapeutics.
NCT05701774 is a Phase 3 study of Prader-Willi Syndrome that is active but no longer recruiting, run by Soleno Therapeutics. The registered enrollment target is 83 participants, above the 66-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05701774, a Phase 3 study of Prader-Willi Syndrome, is active but no longer recruiting, sponsored by Soleno Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.
Primary Outcome
Assess the safety of DCCR by evaluating the incidence and severity of adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. Adverse events will be described by type and level of severity.
Conditions Studied
Interventions
- DRUG DCCR
Study Locations (20)
California
- UC Irvine - Orange
- Stanford University - Palo Alto
- Rady Children's Hospital of San Diego - San Diego
Other
- Fulbourn Hospital - Cambridge
- The Queen Elizabeth University - Glasgow
- Hull and East Yorkshire Hospitals NHS Trust - Hull
Florida
- U of Florida Gainesville - Gainesville
Georgia
- Emory Children's Center - Atlanta
Indiana
- Indiana University School of Medicine - Indianapolis
Maryland
- National Institutes of Health - Bethesda
Massachusetts
- Boston Children's Hospital - Boston
Michigan
- Sparrow Clinical Research Institute - Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2028-06 |
| Phase | Phase 3 |
What the registry record for NCT05701774 still lists
NCT05701774 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 66-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (26% higher).
The record links to 1 condition, with Prader-Willi Syndrome appearing as the primary indexed condition, and to 1 intervention - of which DCCR is the first listed.
NCT05701774 names 20 study sites across 16 states, led by California, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT05701774 about?
NCT05701774 is a clinical study titled "Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome". The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.
What is the current status of trial NCT05701774?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2023-01-31. Estimated completion is 2028-06.
What conditions does trial NCT05701774 study?
This clinical trial studies the following conditions: Prader-Willi Syndrome.
What interventions are being tested in trial NCT05701774?
The interventions under investigation include: DCCR (DRUG).
Who is sponsoring clinical trial NCT05701774?
This trial is sponsored by Soleno Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05701774 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prader-Willi Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05701774's enrollment target sits among peer trials
83 5th of 16 higher than 12 of 16 other Prader-Willi Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prader-Willi Syndrome 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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