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A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome

NCT03440814 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2023-09-21

Study results available
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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.

Conditions

Interventions

DRUG

DCCR

Once daily oral administration

DRUG

Placebo for DCCR

Once daily oral administration

Sponsors & Collaborators

  • Soleno Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Evelien Gevers, MD, PhD · Queen Mary University of London, Barts Health NHS Trust

  • Jennifer L. Miller, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2020-05-01
Completion
2020-05-01
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440814 on ClinicalTrials.gov