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
PHASE3
Gender
ALL
Min Age
4 Years
Max Age
N/A
Download Date
2023-09-21
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: