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NCT03714373 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
A Phase 3 study, sponsored by Soleno Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 115
- Enrollment target
NCT03714373: Completed Phase 3 study, sponsored by Soleno Therapeutics.
NCT03714373 is a Phase 3 study that has completed, run by Soleno Therapeutics. The registered enrollment target is 115 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03714373, a Phase 3 study, has completed, sponsored by Soleno Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 115 participants
- Enrollment target
Study Summary
This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
Primary Outcome
Safety analyses will be conducted in all participants who receive at least one dose of DCCR. Adverse events will be described by type and level of severity.
Interventions
- DRUG DCCR
- DRUG Placebo for DCCR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2023-08-17 |
| Phase | Phase 3 |
What the finished NCT03714373 record still lists
NCT03714373 is an interventional study that assigns participants to a tested intervention. The registered 115 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 (85% lower).
The record links to 0 conditions, and to 2 interventions - of which DCCR is the first listed.
NCT03714373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03714373 about?
NCT03714373 is a clinical study titled "Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period". This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
What is the current status of trial NCT03714373?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 115 participants. The study started on 2018-10-01. Estimated completion is 2023-08-17.
What interventions are being tested in trial NCT03714373?
The interventions under investigation include: DCCR (DRUG), Placebo for DCCR (DRUG).
Who is sponsoring clinical trial NCT03714373?
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 NCT03714373's enrollment target sits among peer trials
115 1644th of 2000 higher than 353 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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