Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Soleno Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: DCCR
  • Drug: Placebo for DCCR

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

4 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alicia Harnett
650-723-0441
Recruiting