Summary

for people ages 4 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion
Virginia Kimonis

Description

Summary

The purpose of this is study is to evaluate the effects of DCCR (diazoxide choline controlled release tablets) in children and adults with Prader-Willi syndrome.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome

Keywords

Prader-Willi SyndromePWSSyndromeCholineDiazoxideDCCR

Eligibility

You can join if…

Open to people ages 4 years and up

  • Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (patients, as appropriate)
  • Genetically-confirmed Prader-Willi syndrome and hyperphagic
  • In a stable care setting for at least 6 months prior to Visit 1
  • Caregiver must have been caring for the patient for at least 6 months prior to Visit 1

You CAN'T join if...

  • Have participated in an interventional clinical study (i.e., investigational drug or device, approved drugs or device evaluated for unapproved use) within prior 3 months
  • Positive urine pregnancy test (in females of child-bearing potential) or females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation
  • Any other known disease and/or condition, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol

Locations

  • University of California, Irvineaccepting new patients
    OrangeCalifornia92868United States
  • Rady Children's Hospital San Diegoaccepting new patients
    San DiegoCalifornia92123United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Soleno Therapeutics, Inc.
ID
NCT03440814
Phase
Phase 3
Study Type
Interventional
Last Updated