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

Phase 3

Active, not recruiting

• Conditions: Prader-Willi Syndrome
• Interventions: Drug: DCCR

• Registration Number: NCT05701774
• Lead Sponsor: Soleno Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-27
• Study Start: 2023-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCCR	DCCR	75 - 525 mg DCCR

Primary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

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; 🇺🇸 St Paul, Minnesota, United States

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