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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:4 - Any
Updated:3/16/2019
Start Date:May 9, 2018
End Date:June 2019
Contact:C601 Project Manager
Email:C601ProjectManager@soleno.life
Phone:650-353-2051

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A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome

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.


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
We found this trial at
14
sites
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Shawn McCandless, MD
Phone: 720-777-8439
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Gainesville, Florida 32611
(352) 392-3261
Principal Investigator: Jennifer L Miller, MD
Phone: 352-294-5280
University of Florida Gainesville UF has a long history of established programs in international education,...
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Gainesville, FL
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: Lynne M. Bird, MD
Phone: 858-966-8453
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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San Diego, CA
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Bethesda, Maryland 20892
Principal Investigator: Jack A Yanovski, MD, Ph.D
Phone: 301-496-6726
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Bethesda, MD
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Amy Fleischman, MD
Phone: 617-918-2867
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Cleveland, Ohio 44012
Principal Investigator: Lori-Anne Schillaci, MD, FAAP
Phone: 216-844-7124
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Cleveland, OH
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Columbus, Ohio 43205
Principal Investigator: Kathryn Obrynba, MD
Phone: 614-722-2630
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Columbus, OH
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Kansas City, Kansas
Principal Investigator: Merlin Butler, MD
Phone: 913-574-0302
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Kansas City, KS
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259 1st Street
Mineola, New York 11501
Principal Investigator: Moris Angulo, MD
Phone: 516-663-9582
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Mineola, NY
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Ashley Hall Shoemaker, MD
Phone: 615-875-3772
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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Orange, California 92868
Principal Investigator: Virginia Kimonis, MD
Phone: 949-824-0521
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Orange, CA
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Palo Alto, California 94304
Principal Investigator: David Stevenson, MD
Phone: 650-723-0441
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345 Smith Avenue North
Saint Paul, Minnesota 55102
Principal Investigator: Jennifer Abuzzahab, MD
Phone: 651-220-5730
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Parisa Salehi, MD
Phone: 206-987-2640
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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