Summary

Eligibility
for people ages 4 years and up (full criteria)
Location
at Orange, California and other locations
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

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