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NCT03440814 · ClinicalTrials.gov registry record · Phase 3
A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
A Phase 3 study, sponsored by Soleno Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 127
- Enrollment target
NCT03440814: Completed Phase 3 study, sponsored by Soleno Therapeutics.
NCT03440814 is a Phase 3 study that has completed, run by Soleno Therapeutics. The registered enrollment target is 127 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03440814, a Phase 3 study, has completed, sponsored by Soleno Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 127 participants
- Enrollment target
Study Summary
The purpose of this is study is to evaluate the effects of DCCR (diazoxide choline controlled release tablets) in children and adults with Prader-Willi syndrome.
Primary Outcome
Hyperphagia-related behaviors were assessed by the validated hyperphagia questionnaire for clinical trials (HQ-CT), an instrument designed to measure symptoms of food related preoccupations and behaviors that was completed by the caregiver. The HQ-CT consists of nine items with responses ranging from 0-4 units each (possible total score range: 0-36). The HQ-CT was assessed at Screening, Baseline (Visit 2), and approximately every 4 weeks post-dose at Week 4, Week 8, and Week 13. A decrease in sc
Interventions
- DRUG DCCR
- DRUG Placebo for DCCR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2020-05-01 |
| Phase | Phase 3 |
What the finished NCT03440814 record still lists
NCT03440814 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which DCCR is the first listed.
NCT03440814 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03440814 about?
NCT03440814 is a clinical study titled "A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome". The purpose of this is study is to evaluate the effects of DCCR (diazoxide choline controlled release tablets) in children and adults with Prader-Willi syndrome.
What is the current status of trial NCT03440814?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 127 participants. The study started on 2018-05-09. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT03440814?
The interventions under investigation include: DCCR (DRUG), Placebo for DCCR (DRUG).
Who is sponsoring clinical trial NCT03440814?
This trial is sponsored by Soleno Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03440814's enrollment target sits among peer trials
127 1602nd of 2000 higher than 398 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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