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

Prader-Willi Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05701774
• Other study ID #: C614
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 31, 2023
• Est. completion date: June 2028

Study information

• Verified date: March 2024
• Source: Soleno Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Intervention

Drug:
• DCCR
Once daily oral administration

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Soleno Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	Baseline to Week 262 or until resolution of certain adverse events