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

Last updated: August 25, 2023
Sponsor: Soleno Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Severe Short Stature

Hypogonadism

Treatment

DCCR

Placebo for DCCR

Clinical Study ID

NCT03440814
C601
  • Ages > 4
  • All Genders

Study 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

Inclusion Criteria:

  • Provide voluntary, written informed consent (parent(s) / legal guardian(s) ofpatient); 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

Exclusion Criteria:

  • Have participated in an interventional clinical study (i.e., investigational drug ordevice, approved drugs or device evaluated for unapproved use) within prior 3 months
  • Positive urine pregnancy test (in females of child-bearing potential) or females whoare pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed duringor within 30 days after study participation
  • Any other known disease and/or condition, which would prevent, in the opinion of theInvestigator, the patient from completing all study visits and assessments required bythe protocol

Study Design

Total Participants: 127
Treatment Group(s): 2
Primary Treatment: DCCR
Phase: 3
Study Start date:
May 09, 2018
Estimated Completion Date:
May 01, 2020

Connect with a study center

  • The Queen Elizabeth University

    Glasgow, Scottland G51 4TF
    United Kingdom

    Site Not Available

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, Yorkshire HU3 2JZ
    United Kingdom

    Site Not Available

  • Birmingham Women's and Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Fulbourn Hospital

    Cambridge, CB21 5ER
    United Kingdom

    Site Not Available

  • Aintree University Hospital NHS Foundation Trust

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • Alder Hey Children's Hospital NHS Foundation Trust

    Liverpool, L12 2AP
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital

    London, SW10 9NH
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, W12 OHS
    United Kingdom

    Site Not Available

  • Royal London Hospital

    London, E1 1BB
    United Kingdom

    Site Not Available

  • University of California, Irvine

    Orange, California 92868
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94305
    United States

    Site Not Available

  • Rady Children's Hospital San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Florida Gainesville

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Emory Children's Center

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • National Institutes of Health Hatfield Clinical Research Center

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Sparrow Clinical Research Institute

    Lansing, Michigan 48912
    United States

    Site Not Available

  • Children's Minnesota

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • St. Joseph's University Medical Center

    Paterson, New Jersey 07503
    United States

    Site Not Available

  • NYU Winthrop Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Research Institute at Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Research Institute of Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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