---
title: Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
nct_id: NCT05701774
overall_status: ACTIVE_NOT_RECRUITING
phase: PHASE3
sponsor: Soleno Therapeutics, Inc.
study_type: INTERVENTIONAL
primary_condition: Prader-Willi Syndrome
countries: United States, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05701774.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05701774"
ct_last_update_post_date: 2025-04-02
last_seen_at: "2026-05-12T06:05:16.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome

**Official Title:** An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome

**NCT ID:** [NCT05701774](https://clinicaltrials.gov/study/NCT05701774)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 83
- **Lead Sponsor:** Soleno Therapeutics, Inc.
- **Conditions:** Prader-Willi Syndrome
- **Start Date:** 2023-01-31
- **Completion Date:** 2028-06
- **CT.gov Last Update:** 2025-04-02

## Brief 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.

## Eligibility

- **Minimum age:** 4 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
2. Participant must:

   1. Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;
   2. Have participated in but discontinued from the Study C602 RW Period and at least 16 weeks have elapsed since the date of their randomization into the C602 RW Period; or
   3. Have participated in Study C602 OLE period, did not consent to participate in the RW Period, and at least 16 weeks have elapsed since the date of their C602 Open-Label Extension End of Treatment Visit.

Exclusion Criteria:

1. Positive urine pregnancy test (in females of child-bearing potential)
2. Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.
3. Participation in a clinical study of an investigational drug (including approved drugs for unapproved uses), investigational device, or therapeutic intervention subsequent to the C602 Open-Label Extension End of Treatment Visit.
```

## Arms

- **DCCR** (EXPERIMENTAL) — 75 - 525 mg DCCR

## Interventions

- **DCCR** (DRUG) — Once daily oral administration

## Primary Outcomes

- **Safety of DCCR (adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. ( Adverse events)** _(time frame: Baseline to End of Study or until resolution of certain adverse events)_ — 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.

## Locations (22)

- UC Irvine, Orange, California, United States
- Stanford University, Palo Alto, California, United States
- Rady Children's Hospital of San Diego, San Diego, California, United States
- U of Florida Gainesville, Gainesville, Florida, United States
- Emory Children's Center, Atlanta, Georgia, United States
- Indiana University School of Medicine, Indianapolis, Indiana, United States
- National Institutes of Health, Bethesda, Maryland, United States
- Boston Children's Hospital, Boston, Massachusetts, United States
- Sparrow Clinical Research Institute, Lansing, Michigan, United States
- Children's Hospital and Clinic Minnesota, Saint Paul, Minnesota, United States
- St. Joseph's University Medical Center, Paterson, New Jersey, United States
- NYU Winthrop Hospital, Mineola, New York, United States
- The Research Institute at Nationwide Children's Hospital, Columbus, Ohio, United States
- Vanderbilt University, Nashville, Tennessee, United States
- Research Institute of Dallas, Dallas, Texas, United States
- University of Utah, Salt Lake City, Utah, United States
- Seattle Children's, Seattle, Washington, United States
- Fulbourn Hospital, Cambridge, United Kingdom
- The Queen Elizabeth University, Glasgow, United Kingdom
- Hull and East Yorkshire Hospitals NHS Trust, Hull, United Kingdom
- Royal London Hospital, London, United Kingdom
- Chelsea and Westminster Hospital, London, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.uc irvine|orange|california|united states` — added _(2026-05-12)_
- `locations.stanford university|palo alto|california|united states` — added _(2026-05-12)_
- `locations.rady children's hospital of san diego|san diego|california|united states` — added _(2026-05-12)_
- `locations.u of florida gainesville|gainesville|florida|united states` — added _(2026-05-12)_
- `locations.emory children's center|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.indiana university school of medicine|indianapolis|indiana|united states` — added _(2026-05-12)_
- `locations.national institutes of health|bethesda|maryland|united states` — added _(2026-05-12)_
- `locations.boston children's hospital|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.sparrow clinical research institute|lansing|michigan|united states` — added _(2026-05-12)_
- `locations.children's hospital and clinic minnesota|saint paul|minnesota|united states` — added _(2026-05-12)_
- `locations.st. joseph's university medical center|paterson|new jersey|united states` — added _(2026-05-12)_
- `locations.nyu winthrop hospital|mineola|new york|united states` — added _(2026-05-12)_
- `locations.the research institute at nationwide children's hospital|columbus|ohio|united states` — added _(2026-05-12)_
- `locations.vanderbilt university|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.research institute of dallas|dallas|texas|united states` — added _(2026-05-12)_
- `locations.university of utah|salt lake city|utah|united states` — added _(2026-05-12)_
- `locations.seattle children's|seattle|washington|united states` — added _(2026-05-12)_
- `locations.fulbourn hospital|cambridge||united kingdom` — added _(2026-05-12)_
- `locations.the queen elizabeth university|glasgow||united kingdom` — added _(2026-05-12)_
- `locations.hull and east yorkshire hospitals nhs trust|hull||united kingdom` — added _(2026-05-12)_
- `locations.royal london hospital|london||united kingdom` — added _(2026-05-12)_
- `locations.chelsea and westminster hospital|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05701774.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05701774*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*