Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
NCT ID: NCT05701774
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
83 participants
INTERVENTIONAL
2023-01-31
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DCCR
75 - 525 mg DCCR
DCCR
Once daily oral administration
Interventions
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DCCR
Once daily oral administration
Eligibility Criteria
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Inclusion Criteria
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
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.
4 Years
ALL
No
Sponsors
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Soleno Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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C614
Identifier Type: -
Identifier Source: org_study_id
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