Study Purpose
Soleno Therapeutics is conducting a Phase 3 study of DCCR to measure the efficacy of the DCCR 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. The initial 15-week study will be followed by a 9-month extension during which time all patients will receive DCCR.
Protocol Update: A recent amendment to the study protocol now allows patients between 20kg and 130kg to enroll in the study, provided they meet all eligibility criteria. Individual study sites will be able to enroll patients in the new weight band (20-30kg) once the appropriate tablet strengths come available, which will likely be in the September timeframe. Patients who are interested in enrolling should contact their nearest study coordinator.
A webinar sharing details on this study was recorded February, 2019. You can watch the webinar below or read a transcription of the webinar on our blog.
Recruitment Criteria
Study Type: Randomized, double-blind, placebo-controlled
Eligible Ages: 4 years and older and at least 20kg
Other Criteria:
Trial Details
Trial Id: NCT03440814
Phase: 3
Duration: 15 weeks, followed by optional 9 month open label extension
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:
United States, California
University of California, Irvine
Orange, California
Contact: Margaret Knight 949-824-0521 mnrobins@uci.edu
Principal Investigator: Virginia Kimonis, MD
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
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado
Principal Investigator: Shawn McCandless, MD
Contact: Marcie Terry 720-777-8439 Marcelle.Terry@childrenscolorado.org
United States, Florida
University of Florida Gainesville
Gainesville, Florida
Principal Investigator: Jennifer L Miller, MD
Contact: Beverly P Giordano, MS, PNP 352-294-5280 bgiordano@ufl.edu
United States, Georgia
Emory Children's Center
Atlanta, Georgia, United States, 30322
Principal Investigator: Eric Felner, MD
Contact: Margaret (Peggy) Jenkins 404-712-0051 mjenk03@emory.edu
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Principal Investigator: Melissa Lah, MD
Contact: Susan Romie 317-278-6650 sromie@iu.edu
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas
Principal Investigator: Merlin Butler, MD
Contact: Yolanda Harness 913-574-0302 yharness@kumc.edu
United States, Maryland
National Institutes of Health
Bethesda, Maryland
Principal Investigator: Jack Yanovski, MD, Ph.D
Contact: Elisabeth Davis, BA 301-496-6726 elisabeth.davis2@nih.gov
Contact: Shelia Brady, MSN 301-451-3783 bradys@mail.nih.gov
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts
Principal Investigator: Amy Fleischman, MD
Contact: Andrea Hale, RN, BSN, MPH, CCRP 617-918-2867 andrea.hale@childrens.harvard.edu
United States, Michigan
Sparrow Clinical Research Institute
Lansing, Michigan
Principal Investigator: Elizabeth Littlejohn, MD
Contact: Jennifer Boak 517-364-5733 jennifer.boak@sparrow.org
United States, Minnesota
Children's Minnesota
Saint Paul, Minnesota
Principal Investigator: Jennifer Abuzzahab, MD
Contact: Brittany Machus, MA, CCRP 651-220-5730 brittany.machus@childrensmn.org
United States, New Jersey
St. Joseph's University Medical Center
Paterson, New Jersey, United States, 07503
Principal Investigator: Katerina Harwood, MD
Contact: JoAnne Daguanno 973-754-3072 daguannj@sjhmc.org
United States, New York
NYU Winthrop Hospital
Mineola, New York
Principal Investigator: Moris Angulo, MD
Contact: Marilyn Richardson 516-663-9582 marilyn.richardson@nyulangone.org
United States, Ohio
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
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Principal Investigator: Kathryn Obrynba, MD
Contact: Emily Viall 614-722-2630 Emily.Viall@nationwidechildrens.org
United States, Tennessee
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
United States, Texas
Research Institute of Dallas
Dallas, Texas
Principal Investigator: Heidi Shea
Contact: Satanya Brooks, tbrooks@researchdallas.com 214-265-2137
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84113
Principal Investigator: David Viskochil, MD
Contact: Carrie Bailey 801-587-3605 Carrie.Bailey@hsc.utah.edu
United States, Washington
Seattle Children's Hospital
Seattle, Washington
Principal Investigator: Parisa Salehi, MD
Contact: Sue Kearns, BMS 206-987-2640 sue.kearns@seattlechildrens.org
United Kingdom
The Queen Elizabeth University
Glasgow, Scottland, United Kingdom, G51 4TF
Contact: Barry Milligan barry.milligan@ggc.scot.nhs.uk
Principal Investigator: Mohammed Shaikh
Hull and East Yorkshire Hospitals NHS Trust
Hull, Yorkshire, United Kingdom, HU3 2JZ
Contact Leanne Sherris 44 1482 676483 leanne.sherris@hey.nhs.uk
Principal Investigator: Verghese Mathew
Birmingham Women's and Children's Hospital
Birmingham, United Kingdom, B4 6NH
Contact: Timothy Barrett Tim.barrett1@nhs.net
Principal Investigator: Timothy Barrett
Fulbourn Hospital
Cambridge, United Kingdom, CB21 5ER
Contact: Katie Keating-Fedders 1223 219528 Katie.Keating-Fedders@cpft.nhs.uk
Principal Investigator: Tony Holland
Alder hey Children's Hospital NHS Foundation Trust
Liverpool, United Kingdom, L12 2AP
Contact: Rebecca Donegan 44 151 525744 ext 2744 rebecca.donegan@alderhey.nhs.uk
Principal Investigator: Jon Wilding
Aintree University Hospital NHS Foundation Trust
Liverpool, United Kingdom, L9 7AL
Contact: Shirley Cooper 151-529-5215 shirley.cooper@aintree.nhs.uk
Principal Investigator: Jon Wilding
Royal London Hospital
London, United Kingdom, E1 1BB
Contact: Tara Murray 020 5941455 tara.murray@bartshealth.nhs.uk
Principal Investigator: Evelien Gevers
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Contact: Rhian Bull Rhian.Bull@chelwest.nhs.uk
Principal Investigator: Nicola Bridges
Hammersmith Hospital
London, United Kingdom, W12 OHS
Contact: Aime Boakye aime.boakye@nhs.net
Principal Investigator: Tony Goldstone
