NCT05701774CompletedPhase 3
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 77 (actual)
- First submitted
- 18 Jan 2023
- Start date
- 31 Jan 2023
- Primary completion date
- 12 Jan 2026
- Lead sponsor
- Soleno Therapeutics, Inc.
- NCT number
- NCT05701774
- EudraCT number
- 2025-000181-28
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 77
- From 31 Jan 2023 to the primary completion date, 12 Jan 2026
- 21 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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; or
- 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.
Age in the registry: 4 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.