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

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