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

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

ArmDescriptionAssigned Intervention
Experimental
DCCR
75 - 450 mg DCCR
  • Drug: DCCR
    Once daily oral administration
Placebo Comparator
Placebo
75 - 450 mg placebo for DCCR
  • Drug: Placebo for DCCR
    Once daily oral administration

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37232
Contact:
Sarah N McKeel, R.N., BSN
615-875-3772
sarah.n.mckeel@vumc.org

More Details

NCT ID
NCT03440814
Status
Recruiting
Sponsor
Soleno Therapeutics, Inc.

Study Contact

C601 Project Manager
650-353-2051
C601ProjectManager@soleno.life

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.