Open-Label Extension 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:3/10/2019
Start Date:October 1, 2018
End Date:February 2020
Contact:C602 Project Manager
Email:C602ProjectManager@soleno.life
Phone:650-353-2051

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An Open-Label, Long-Term Safety Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome

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


Key Inclusion Criteria:

- Successful completion of clinical study C601

- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
patient); provide voluntary, written assent (subjects, as appropriate)

Key Exclusion Criteria:

- 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 90 days after study participation

- Any new disease, condition, or circumstance which would prevent, in the opinion of the
Investigator, the patient from completing all study visits and assessments required by
the protocol (e.g., an anticipated change of care setting)
We found this trial at
7
sites
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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Cleveland, Ohio 44012
Principal Investigator: Lori-Anne Schillaci, MD, FAAP
Phone: 216-844-7124
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Cleveland, OH
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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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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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Seattle, WA
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