Summary

Eligibility
for people ages 4 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

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.

Official Title

An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome

Keywords

Prader-Willi Syndrome, Syndrome, DCCR

Eligibility

You can join if…

Open to people ages 4 years and up

  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.

You CAN'T join if...

  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.

Locations

  • UC Irvine
    Orange California 92868 United States
  • Rady Children's Hospital of San Diego
    San Diego California 92123 United States
  • Stanford University
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Soleno Therapeutics, Inc.
ID
NCT05701774
Phase
Phase 3 Prader-Willi Syndrome Research Study
Study Type
Interventional
Participants
Expecting 83 study participants
Last Updated