CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 127 enrolled
Drug / intervention
DCCR +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03440814
NCT03440814Phase 3Completed

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

Soleno Therapeutics, Inc.·interventional·Posted Feb 22, 2018·Updated Sep 21, 2023

In Brief

A Phase 3 clinical trial evaluating DCCR and Placebo for DCCR for Prader-Willi Syndrome. Completed, enrolled 127 participants across 29 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 22, 2018
Enrollment StartMay 9, 2018
Primary CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.4 years ago

Interventions

DCCRdrug

Once daily oral administration

Placebo for DCCRdrug

Once daily oral administration