Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
NCT ID: NCT03714373
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
115 participants
INTERVENTIONAL
2018-10-01
2023-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OLE DCCR
75 - 525 mg DCCR
DCCR
Once daily oral administration of open-label DCCR tablet(s) during the OLE Period
RW DCCR
75 - 525 mg DCCR
DCCR
Once daily oral administration of double-blind (DCCR) tablet(s) during the RW Period
RW Placebo
75 - 525 mg Placebo for DCCR
Placebo for DCCR
Once daily oral administration of double-blind (placebo for DCCR) tablet(s) during the RW Period
Interventions
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DCCR
Once daily oral administration of open-label DCCR tablet(s) during the OLE Period
DCCR
Once daily oral administration of double-blind (DCCR) tablet(s) during the RW Period
Placebo for DCCR
Once daily oral administration of double-blind (placebo for DCCR) tablet(s) during the RW Period
Eligibility Criteria
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Inclusion Criteria
* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
* Provide voluntary, written informed consent (parent\[s\] / legal guardian\[s\] of participant); provide voluntary, written assent (participants, as appropriate); this includes consent for randomization and potential treatment with placebo for up to 16 weeks
* Currently participating in clinical study C602 and complete the OLE End of Treatment Visit procedures
Exclusion Criteria
* 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)
* Positive urine pregnancy test (in females of child-bearing potential)
* Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation
4 Years
ALL
No
Sponsors
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Soleno Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California, Irvine
Orange, California, United States
Stanford University
Palo Alto, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
University of Florida Gainesville
Gainesville, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
National Institutes of Health Hatfield Clinical Research Center
Bethesda, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Children's Minnesota
Saint Paul, Minnesota, United States
St. Joseph's University Medical Center
Paterson, New Jersey, United States
NYU Winthrop Hospital
Mineola, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States
Vanderbilt University
Nashville, Tennessee, United States
Research Institute of Dallas
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
The Queen Elizabeth University
Glasgow, Scottland, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, Yorkshire, United Kingdom
Birmingham Women's and Children's Hospital
Birmingham, , United Kingdom
Fulbourn Hospital
Cambridge, , United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Royal London Hospital
London, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Countries
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References
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Strong TV, Miller JL, McCandless SE, Gevers E, Yanovski JA, Matesevac L, Bohonowych J, Ballal S, Yen K, Hirano P, Cowen NM, Bhatnagar A. Behavioral changes in patients with Prader-Willi syndrome receiving diazoxide choline extended-release tablets compared to the PATH for PWS natural history study. J Neurodev Disord. 2024 Apr 26;16(1):22. doi: 10.1186/s11689-024-09536-x.
Miller JL, Gevers E, Bridges N, Yanovski JA, Salehi P, Obrynba KS, Felner EI, Bird LM, Shoemaker AH, Angulo M, Butler MG, Stevenson D, Goldstone AP, Wilding J, Lah M, Shaikh MG, Littlejohn E, Abuzzahab MJ, Fleischman A, Hirano P, Yen K, Cowen NM, Bhatnagar A; C601/C602 Investigators. Diazoxide choline extended-release tablet in people with Prader-Willi syndrome: results from long-term open-label study. Obesity (Silver Spring). 2024 Feb;32(2):252-261. doi: 10.1002/oby.23928. Epub 2023 Nov 2.
Other Identifiers
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C602
Identifier Type: -
Identifier Source: org_study_id
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