Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome

Last updated: March 28, 2025
Sponsor: Soleno Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hypogonadism

Severe Short Stature

Treatment

DCCR

Clinical Study ID

NCT05701774
C614
  • Ages > 4
  • All Genders

Study Summary

The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provide voluntary, written informed consent (parent(s) / legal guardian(s) ofpatient); provide voluntary, written assent (subjects, as appropriate)

  2. Participant must:

  3. Have participated in and completed the Study C602 Randomized Withdrawal (RW)Period;

  4. Have participated in but discontinued from the Study C602 RW Period and atleast 16 weeks have elapsed since the date of their randomization into the C602RW Period; or

  5. Have participated in Study C602 OLE period, did not consent to participate inthe RW Period, and at least 16 weeks have elapsed since the date of their C602Open-Label Extension End of Treatment Visit.

Exclusion

Exclusion Criteria:

  1. Positive urine pregnancy test (in females of child-bearing potential)

  2. Females who are pregnant or breastfeeding, and/or plan to become pregnant or tobreast-feed during or within 30 days after study participation.

  3. Participation in a clinical study of an investigational drug (including approveddrugs for unapproved uses), investigational device, or therapeutic interventionsubsequent to the C602 Open-Label Extension End of Treatment Visit.

Study Design

Total Participants: 83
Treatment Group(s): 1
Primary Treatment: DCCR
Phase: 3
Study Start date:
January 31, 2023
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Fulbourn Hospital

    Cambridge, CB21 5EF
    United Kingdom

    Site Not Available

  • The Queen Elizabeth University

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital

    London, SW10 9NH
    United Kingdom

    Site Not Available

  • Royal London Hospital

    London, E1 1BB
    United Kingdom

    Site Not Available

  • UC Irvine

    Orange, California 92868
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Rady Children's Hospital of San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • U of Florida Gainesville

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Emory Children's Center

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • National Institutes of Health

    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 Hospital and Clinic Minnesota

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Children's Hospital and Clinic Minnesota

    St 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

  • The Research Institute at Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Research Institute of Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Seattle Children's

    Seattle, Washington 98105
    United States

    Site Not Available

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