Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
Public ClinicalTrials.gov record NCT03714373. 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
An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Extended-Release Tablets in Participants With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
Study identification
- NCT ID
- NCT03714373
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Soleno Therapeutics, Inc.
- Industry
- Enrollment
- 115 participants
Conditions and interventions
Conditions
Interventions
- DCCR Drug
- Placebo for DCCR Drug
Drug
Eligibility (public fields only)
- Age range
- 4 Years and older
- 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 30, 2018
- Primary completion
- Aug 16, 2023
- Completion
- Aug 16, 2023
- Last update posted
- Apr 18, 2024
2018 – 2023
United States locations
- U.S. sites
- 20
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Irvine | Orange | California | 92868 | — |
| Stanford University | Palo Alto | California | 94305 | — |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| University of Florida Gainesville | Gainesville | Florida | 32608 | — |
| Emory Children's Center | Atlanta | Georgia | 30322 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| National Institutes of Health Hatfield Clinical Research Center | Bethesda | Maryland | 20892 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | — |
| Children's Minnesota | Saint Paul | Minnesota | 55102 | — |
| St. Joseph's University Medical Center | Paterson | New Jersey | 07503 | — |
| NYU Winthrop Hospital | Mineola | New York | 11501 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Vanderbilt University | Nashville | Tennessee | 37212 | — |
| Research Institute of Dallas | Dallas | Texas | 75231 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
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 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03714373, 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 Apr 18, 2024 · Synced Jul 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 protocol, eligibility criteria, and contact information for NCT03714373 live on ClinicalTrials.gov.