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

Phase

PHASE3

Gender

ALL

Min Age

4 Years

Max Age

N/A

Download Date

2023-09-21

Principal Investigator

N/A

Intervention

Intervention Type

DRUG

DRUG

Intervention Name

DCCR

Placebo for DCCR

Contact

For more information and to contact the study team:

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