Diazoxide ( DrugBank: Diazoxide )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎1
193プラダー・ウィリ症候群8

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-023048-34-DE
(EUCTR)
31/08/201110/05/2011A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of low doses of oral Diazoxide for the treatment of Multiple Sclerosis.A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of low doses of oral Diazoxide for the treatment of Multiple Sclerosis. - NeuroAdvan Multiple Sclerosis Treatment.
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Diazoxide
Product Code: Diazoxide
INN or Proposed INN: Diazoxide
Product Name: Diazoxide
Product Code: Diazoxide
INN or Proposed INN: Diazoxide
NEUROTEC PHARMA, S.LNULLNot RecruitingFemale: yes
Male: yes
99Phase 2Spain;Germany

193. プラダー・ウィリ症候群


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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