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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05701774
Other study ID # C614
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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