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Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome | Clinical Trials | Clareo Health

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

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

NCT05701774•Soleno Therapeutics, Inc.

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

Age

4 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Key Dates

Start Date

January 31, 2023

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2028

Last Updated

April 2, 2025

Enrollment

ESTIMATED participants

Conditions

Prader-Willi Syndrome

Interventions

DCCR

DRUG

Institutional Registry of Rare Diseases

NCT06573723

Rare DiseasesAmyloidosis+24 more

View study

RECRUITING

Register of Patients With Prader-Willi Syndrome

NCT02829684

Prader-Willi Syndrome

View study

RECRUITING

GROWing Up With Rare GENEtic Syndromes

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Institutional Registry of Rare Diseases

Register of Patients With Prader-Willi Syndrome

GROWing Up With Rare GENEtic Syndromes

OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial

Improving Care of Prader-Willi Syndrome : Evaluation of a New Care Program Combining Adapted Physical Activity, Nutrition and Therapeutic Education