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

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Jun 2028 to Jan 12, 2026
    • Enrollment target: estimated 83 to confirmed 77
    • Study completion date changed from estimate of Jun 2028 to Apr 29, 2026
    • Eligibility criteria expanded, about 8 words
    • Study sites revised (22)
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 22
    v2
  4. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05701774
Lead Sponsor Soleno Therapeutics, Inc.
Conditions
(from sponsor)		 Prader-Willi Syndrome
Related terms Prader-Willi Syndrome
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov