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Not Yet Recruiting NCT05701774

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

Conditions: Prader-Willi Syndrome

Sex: All
Ages: 4 Years – N/A
Phase: PHASE3
Enrollment: 83
Sponsor: 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 Criteria

Inclusion Criteria:Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)Participant must:Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;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; orHave 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:Positive urine pregnancy test (in females of child-bearing potential)Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05701774). StuddyBuddy aggregates publicly available trial information.