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 | 
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.
			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
	
			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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									13123 E 16th Ave
Aurora, Colorado 80045
	
			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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								Bethesda, Maryland 20892			
	
			
					Principal Investigator: Jack A Yanovski, MD, Ph.D
			
						
										Phone: 301-496-6726
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									300 Longwood Ave
Boston, Massachusetts 02115
	
			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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								Columbus, Ohio 43205			
	
			
					Principal Investigator: Kathryn Obrynba, MD
			
						
										Phone: 614-722-2630
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								Kansas City, Kansas 			
	
			
					Principal Investigator: Merlin Butler, MD
			
						
										Phone: 913-574-0302
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									259 1st Street
Mineola, New York 11501
	
			
					Mineola, New York 11501
Principal Investigator: Moris Angulo, MD
			
						
										Phone: 516-663-9582
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									2201 West End Ave
Nashville, Tennessee 37232
	
			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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								Orange, California 92868			
	
			
					Principal Investigator: Virginia Kimonis, MD
			
						
										Phone: 949-824-0521
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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
	
			
					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
	
			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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