A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
Purpose
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.
Condition
- Prader-Willi Syndrome
Eligibility
- Eligible Ages
- Over 4 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental DCCR |
75 - 450 mg DCCR |
|
|
Placebo Comparator Placebo |
75 - 450 mg placebo for DCCR |
|
More Details
- Status
- Completed
- Sponsor
- Soleno Therapeutics, Inc.