DCCR for the Treatment of Hyperphagia in PWS

Study Purpose

Soleno Therapuetics is conducting a Phase 3 study of DCCR to measure the drugs efficacy for treating hyperphagia in PWS. The study seeks to enroll 105 patients with PWS ages 4 years and older. The study will be a 15 week, randomized, double-blind, placebo-controlled study of Diazoxide Choline Controlled-Release Tablet (DCCR) and will require a once daily oral administration. Five sites are now open with additional sites expected to open soon.

Recruitment Criteria

Study Type: Randomized, double-blind, placebo-controlled
Eligible Ages: 4 years and older
Other Criteria:

Trial Details

Trial IdNCT03440814
Phase: 3
Duration: 15 weeks
Status:
 recruiting
Lead Sponsor: Soleno
Countries: United States
Additional Details: 

Eligibility Criteria

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
  • 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

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. More information on this study is available on the study information page at clincaltrials.gov.

This Study is enrolling at the following sites:

Stanford University
Palo Alto, California
Principal Investigator: David Stevenson, MD
Contact: Alicia Harnett    650-723-0441    aharnett@stanford.edu   

Rady Children's Hospital
San Diego, California
Principal Investigator: Lynne M. Bird, MD 
Contact: Rachel Winograd, R.N.    858-966-8453    Rwinograd@rchsd.org 

Children's Hospital Colorado
Aurora, Colorado
Principal Investigator: Christine L Chan, MD
Contact: Marcie Terry    720-777-8439    Marcelle.Terry@childrenscolorado.org

University of Florida Gainesville
Gainesville, Florida
Principal Investigator: Jennifer L Miller, MD
Contact: Beverly P Giordano, MS, PNP 352-294-5280  bgiordano@ufl.edu

NYU Winthrop Hospital

Mineola, New York
Principal Investigator: Moris Angulo, MD
Contact: Marilyn Richardson    516-663-9582    marilyn.richardson@nyulangone.org 

University Hospitals Cleveland Medical Center
Cleveland, Ohio
Principal Investigator: Lori-Anne Schillaci, MD, FAAP
Contact: Audrey Lynn, Ph.D    216-844-7124    audrey.lynn@uhhospitals.org

Children's Minnesota
Saint Paul, Minnesota
Principal Investigator: Jennifer Abuzzahab, MD
Contact: Brittany Machus, MA, CCRP 651-220-5730 brittany.machus@childrensmn.org

Vanderbilt University
Nashville, Tennessee
Principal Investigator: Ashley Hall Shoemaker, MD
Contact: Sarah N McKeel, R.N., BSN    615-875-3772    sarah.n.mckeel@vumc.org

Seattle Children's Hospital
Seattle, Washington
Principal Investigator: Parisa Salehi, MD
Contact: Sue Kearns, BMS 206-987-2640 sue.kearns@seattlechildrens.org

 

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