A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
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ClinicalTrials.gov Identifier: NCT03440814 |
Recruitment Status :
Completed
First Posted : February 22, 2018
Last Update Posted : June 26, 2020
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Sponsor:
Soleno Therapeutics, Inc.
Information provided by (Responsible Party):
Soleno Therapeutics, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | February 13, 2018 | ||||
First Posted Date ICMJE | February 22, 2018 | ||||
Last Update Posted Date | June 26, 2020 | ||||
Actual Study Start Date ICMJE | May 9, 2018 | ||||
Actual Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Hyperphagia Score [ Time Frame: Baseline to Week 13 ] Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome | ||||
Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Prader-Willi Syndrome | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
127 | ||||
Original Estimated Enrollment ICMJE |
105 | ||||
Actual Study Completion Date ICMJE | May 1, 2020 | ||||
Actual Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 4 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03440814 | ||||
Other Study ID Numbers ICMJE | C601 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Soleno Therapeutics, Inc. | ||||
Study Sponsor ICMJE | Soleno Therapeutics, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Soleno Therapeutics, Inc. | ||||
Verification Date | December 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |