Clinical Trials Logo
  1. Home
  2. Prader-Willi Syndrome
  3. NCT03714373

Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period

Prader-Willi Syndrome Clinical Trial

Official title:
An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Extended-Release Tablets in Participants With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period

Clinical Trial Summary

This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.

Clinical Trial Description

115 PWS participants who completed clinical study C601 will be enrolled into the OLE Period. All participants in the Open Label Extension (OLE) Period will receive open-label DCCR. The actual number of participants eligible to enroll in the double-blind, placebo-controlled, randomized withdrawal (RW) period will be limited to those participants taking DCCR in the OLE Period at the time of the RW Period Visit 1 (Baseline/Randomization Visit).The treatment groups in the C602 RW Period are those participants randomized to receive DCCR and those participants randomized to receive Placebo. Participants will be randomized in a 1:1 ratio (DCCR:Placebo). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03714373
Study type Interventional
Source Soleno Therapeutics, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 1, 2018
Completion date August 17, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05032326 - Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial Phase 3
Completed NCT04526379 - Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation N/A
Terminated NCT03458416 - A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome Phase 2
Completed NCT03718416 - Natural History Study of Serious Medical Events in PWS
Completed NCT05322096 - Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome Phase 2
Completed NCT02205450 - Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell
Terminated NCT02179151 - Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome Phase 3
Completed NCT00375089 - Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity N/A
Completed NCT00004351 - Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes N/A
Recruiting NCT05938543 - Cerebellar TMS and Satiety in Prader-Willi Syndrome N/A
Suspended NCT05879614 - An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001) Phase 2
Recruiting NCT03031626 - Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome Phase 4
Withdrawn NCT04086810 - An Open-Label Study of DCCR Tablet in Patients With PWS Phase 3
Completed NCT02629991 - Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome Phase 2
Recruiting NCT02297022 - Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome Phase 1
Not yet recruiting NCT02263781 - PREPL in Health and Disease N/A
Completed NCT00551343 - Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome N/A
Recruiting NCT06448871 - Ultrasound to Assess Sarcopenia in Prader Willi Syndrome
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Recruiting NCT05939453 - Impact of Bright Light Therapy on Prader-Willi Syndrome N/A