193. プラダー・ウィリ症候群 Prader-Willi syndrome Clinical trials / Disease details


臨床試験数 : 113 薬物数 : 111 - (DrugBank : 26) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 102

  
8 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05701774
(ClinicalTrials.gov)
January 31, 202318/1/2023Open-Label Extension Study of DCCR in Patients With Prader-Willi SyndromeAn Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: DCCRSoleno Therapeutics, Inc.NULLNot yet recruiting4 YearsN/AAll83Phase 3NULL
2NCT04086810
(ClinicalTrials.gov)
October 201910/9/2019An Open-Label Study of DCCR Tablet in Patients With PWSAn Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: DCCRSoleno Therapeutics, Inc.NULLWithdrawn4 YearsN/AAll0Phase 3NULL
3EUCTR2018-004216-22-GB
(EUCTR)
25/09/201927/06/2019A study to determine the safety of the study drug Diazoxide Choline Controlled-Release Tablet after being given for a long time to patients with the genetic disorder Prader-Willi Syndrome.An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome Hyperphagia associated with Prader-Willi Syndrome (PWS)
MedDRA version: 20.0;Level: PT;Classification code 10020710;Term: Hyperphagia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: diazoxide choline
Product Code: DCCR
INN or Proposed INN: Diazoxide choline
Other descriptive name: DIAZOXIDE CHOLINE
Soleno Therapeutics UK Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;United Kingdom
4EUCTR2018-004215-50-GB
(EUCTR)
23/04/201912/08/2019A study to evaluate the effects of a medicine named diazoxide choline in patients with the genetic disorder Prader-Willi syndrome.A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients with Prader-Willi Syndrome Hyperphagia associated with Prader-Willi Syndrome.
MedDRA version: 20.0;Level: PT;Classification code 10020710;Term: Hyperphagia;System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: diazoxide choline
Product Code: DCCR
INN or Proposed INN: Diazoxide choline
Other descriptive name: DIAZOXIDE CHOLINE
Soleno Therapeutics UK Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;United Kingdom
5NCT03714373
(ClinicalTrials.gov)
October 1, 201827/9/2018Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal PeriodAn Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Extended-Release Tablets in Participants With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal PeriodPrader-Willi SyndromeDrug: DCCR;Drug: Placebo for DCCRSoleno Therapeutics, Inc.NULLActive, not recruiting4 YearsN/AAll115Phase 3United States;United Kingdom
6NCT03440814
(ClinicalTrials.gov)
May 9, 201813/2/2018A Study of Diazoxide Choline in Patients With Prader-Willi SyndromeA Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: DCCR;Drug: Placebo for DCCRSoleno Therapeutics, Inc.NULLCompleted4 YearsN/AAll127Phase 3United States;United Kingdom
7NCT02893618
(ClinicalTrials.gov)
July 201730/8/2016A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)Prader-Willi SyndromeDrug: Diazoxide choline controlled-release tabletEssentialis, Inc.NULLNot yet recruiting18 Years65 YearsBoth32Phase 2NULL
8NCT02034071
(ClinicalTrials.gov)
April 20148/1/2014Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi SyndromeA Dose Titration Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal ExtensionPrader-Willi SyndromeDrug: DCCR;Drug: PlaceboEssentialis, Inc.NULLCompleted10 Years22 YearsBoth13Phase 1/Phase 2United States