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
Cleveland, Ohio 44012
Principal Investigator: Lori-Anne Schillaci, MD, FAAP
Phone: 216-844-7124
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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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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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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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Aurora, CO
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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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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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Palo Alto, CA
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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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Saint Paul, MN
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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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