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Clinical Trials in the USA / NCT05701774
Active, not recruiting Phase 3

Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome

NCT05701774 · tracked via the Priya Life Science USA tracker
Sponsor
Soleno Therapeutics, Inc.
Phase
Phase 3
Started
2023-01-31
Last updated
2025-04-02

Condition(s) studied

Prader-Willi Syndrome

Investigational drug(s) / intervention(s)

DCCR

DCCR: Once daily oral administration

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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
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.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
UC Irvine Orange California
Stanford University Palo Alto California
Rady Children's Hospital of San Diego San Diego California
U of Florida Gainesville Gainesville Florida
Emory Children's Center Atlanta Georgia
Indiana University School of Medicine Indianapolis Indiana
National Institutes of Health Bethesda Maryland
Boston Children's Hospital Boston Massachusetts
Sparrow Clinical Research Institute Lansing Michigan
Children's Hospital and Clinic Minnesota Saint Paul Minnesota
St. Joseph's University Medical Center Paterson New Jersey
NYU Winthrop Hospital Mineola New York
The Research Institute at Nationwide Children's Hospital Columbus Ohio
Vanderbilt University Nashville Tennessee
Research Institute of Dallas Dallas Texas
University of Utah Salt Lake City Utah
Seattle Children's Seattle Washington
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

More Soleno Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05701774 on ClinicalTrials.gov ↗ ← All trials in the USA