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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

Prader-Willi Syndrome

Recruitment Status

Completed

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Intervention

Intervention Type

Intervention Name

Drug

DCCR

Drug

Placebo for DCCR

Phase

Phase 3

Gender

All

Min Age

4 Years

Max Age

N/A

Download Date

September 21, 2023

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome NCT03440814