Status:
COMPLETED
A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
Lead Sponsor:
Soleno Therapeutics, Inc.
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT03440814
Start Date
May 9 2018
End Date
May 1 2020
Last Update
September 21 2023
Active Locations (29)
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1
University of California, Irvine
Orange, California, United States, 92868
2
Stanford University
Palo Alto, California, United States, 94305
3
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045