Valproate ( DrugBank: Valproate )


6 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症2
3脊髄性筋萎縮症2
90網膜色素変性症1
102ルビンシュタイン・テイビ症候群1
233ウォルフラム症候群6
256筋型糖原病3

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03204500
(ClinicalTrials.gov)
May 201628/6/2017Dual Treatment With Lithium and Valproate in ALS.A Randomized Clinical Trial, Double Blind, Placebo-controlled of Lithium and Valproate in Amyotrophic Lateral Sclerosis.Amyotrophic Lateral Sclerosis;Amyotrophic Lateral Sclerosis, SporadicCombination Product: Active treatment with dual therapy;Drug: PlacebosEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezNULLCompleted40 Years70 YearsAll43Phase 2Mexico
2NCT00136110
(ClinicalTrials.gov)
April 200524/8/2005Trial of Sodium Valproate in Amyotrophic Lateral SclerosisA Randomized, Double-Blind, Placebo-Controlled Sequential Clinical Trial of Sodium Valproate in ALSAmyotrophic Lateral SclerosisDrug: Sodium ValproateUMC UtrechtPrincess Beatrix Fund, The NetherlandsCompleted18 Years85 YearsBoth165Phase 3Netherlands

3. 脊髄性筋萎縮症


臨床試験数 : 237 薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 75
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01671384
(ClinicalTrials.gov)
August 201313/8/2012Valproate and Levocarnitine in Children With Spinal Muscular AtrophyRandomized Placebo Controlled Trial of Valproate and Levocarnitine in Children With Spinal Muscular Atrophy Aged 2-15 YearsSpinal Muscular AtrophyDrug: Valproate, Levocarnitine;Drug: PlaceboAll India Institute of Medical Sciences, New DelhiNULLRecruiting2 Years15 YearsBoth60Phase 3India
2EUCTR2008-003915-11-DE
(EUCTR)
24/09/200925/06/2009Phase I/II Trial of Valproic Acid and Carnitine in Infants with Spinal Muscular Atrophy Type I (CARNI-VAL Type I) - CARNI-VAL Type IPhase I/II Trial of Valproic Acid and Carnitine in Infants with Spinal Muscular Atrophy Type I (CARNI-VAL Type I) - CARNI-VAL Type I Spinal Muscular Atrophy Type I in infants
MedDRA version: 9.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital
Trade Name: Orfiril Saft
INN or Proposed INN: VALPROATE SODIUM
Trade Name: Biocarn
INN or Proposed INN: LEVOCARNITINE
University of UtahNULLNot RecruitingFemale: yes
Male: yes
36Phase 1/2Germany

90. 網膜色素変性症


臨床試験数 : 147 薬物数 : 176 - (DrugBank : 43) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 110
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JMA-IIA00053
24/12/201022/11/2010Clinical Trial of Therapeutic Effect of Valproic Acid in Retinitis PigmentosaClinical Trial of Therapeutic Effect of Valproic Acid in Retinitis Pigmentosa Retinitis PigmentosaIntervention type:DRUG. Intervention1:Sodium valproate, Dose form:TABLET, Route of administration:ORAL.Yasuhiko HiramiMasayo Takahashi, Yasuo KurimotoCompleted>=20 YEARSNo LimitBOTH30NOT APPLICABLEJapan

102. ルビンシュタイン・テイビ症候群


臨床試験数 : 3 薬物数 : 5 - (DrugBank : 1) / 標的遺伝子数 : 7 - 標的パスウェイ数 : 17
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01619644
(ClinicalTrials.gov)
April 201212/6/2012Rubinstein-Taybi Syndrome: Functional Imaging and Therapeutic TrialRubinstein-Taybi Syndrome: Functional Imaging and Therapeutic TrialRubinstein-Taybi SyndromeDrug: sodium valproate;Drug: PlaceboUniversity Hospital, BordeauxFondation Syndrome de Rubinstein-TaybiCompleted6 Years21 YearsBoth41Phase 2France

233. ウォルフラム症候群


臨床試験数 : 11 薬物数 : 17 - (DrugBank : 8) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 41
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04940572
(ClinicalTrials.gov)
November 26, 202111/5/2021Efficacy Study of Daily Administration of VPA in Patients Affected by Wolfram SyndromeAUDIOWOLF: A Phase II, Open-label, Efficacy Study of Daily Administration of Sodium Valproate in Patients Clinically Affected by Wolfram Syndrome Due to Monogenic Mutation.Wolfram SyndromeDrug: DepakineCentre d'Etude des Cellules SouchesGenethonRecruiting13 YearsN/AAll23Phase 2France
2EUCTR2017-001215-37-PL
(EUCTR)
13/02/202010/10/2019Clinical Trial of a Treatment to Slow Disease Progression Compared to Usual Standard of Care in Children and Adults with WolframA pivotal, international, randomised, double-blind, efficacy and safety trial of sodium valporate in paediatric and adult patients with Wolfram Syndrome - Treat Wolfram Wolfram syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Sodium valproate 200 mg gastro-resistant tabletsUniversity of BirminghamNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2France;Poland;United Kingdom
3NCT03717909
(ClinicalTrials.gov)
December 28, 201811/10/2018Efficacy and Safety Trial of Sodium Valproate, in Paediatric and Adult Patients With Wolfram SyndromeA Pivotal, International, Randomised, Double-blind, Efficacy and Safety Trial of Sodium Valproate, in Paediatric and Adult Patients With Wolfram SyndromeWolfram SyndromeDrug: Sodium Valproate 200Mg E/C Tablet;Drug: Sodium Valproate matched placeboUniversity of BirminghamNULLRecruiting5 YearsN/AAll70Phase 2France;Poland;Spain;United Kingdom
4EUCTR2017-001215-37-GB
(EUCTR)
19/03/201821/06/2018 Clinical Trial of a Treatment to Slow Disease Progression Compared to Usual Standard of Care in Children and Adults with Wolfram.A pivotal, international, randomised, double-blind, efficacy and safety trial of sodium valporate in paediatric and adult patients with Wolfram Syndrome - Treat Wolfram Wolfram syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Sodium Valproate Wockhardt 200mg Gastro-Resistant tablets
Product Name: Sodium Valproate Wockhardt 200mg Gastro-Resistant tablets
University of BirminghamNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Poland;Spain;United Kingdom
5EUCTR2020-004594-43-FR
(EUCTR)
11/03/2021AUDIOWOLF: A phase II, open-label, efficacy study of daily administration of sodium valproate in patients clinically affected by Wolfram syndrome due to monogenic mutationAUDIOWOLF: A phase II, open-label, efficacy study of daily administration of sodium valproate in patients clinically affected by Wolfram syndrome due to monogenic mutation - AUDIOWOLF Wolfram syndrome
MedDRA version: 20.0;Level: PT;Classification code 10078338;Term: Wolfram syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: DEPAKINE CHRONO® 500 mg
Product Name: DEPAKINE CHRONO 500 mg
CECS/I-StemNULLNAFemale: yes
Male: yes
23Phase 2France
6EUCTR2017-001215-37-FR
(EUCTR)
03/02/2020Clinical Trial of a Treatment to Slow Disease Progression Compared to Usual Standard of Care in Children and Adults with Wolfram. A pivotal, international, randomised, double-blind, efficacy and safety trial of sodium valporate in paediatric and adult patients with Wolfram Syndrome - Treat Wolfram Wolfram syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Sodium Valproate Wockhardt 200mg Gastro-Resistant tablets
Product Name: Sodium Valproate Wockhardt 200mg Gastro-Resistant tablets
University of BirminghamNULLNAFemale: yes
Male: yes
70Phase 2France;Spain;Poland;United Kingdom

256. 筋型糖原病


臨床試験数 : 180 薬物数 : 133 - (DrugBank : 29) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 105
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03112889
(ClinicalTrials.gov)
January 201511/8/2015Sodium Valproate for GSDVA Phase II Pilot Study to Explore Treatment With Sodium Valproate in Adults With McArdle Disease (Glycogen Storage Disorder Type V, GSDV)Glycogen Storage Disease Type V;McArdle DiseaseDrug: Sodium ValproateUniversity College, LondonNULLCompleted18 Years64 YearsAll8Phase 2Denmark;United Kingdom
2EUCTR2014-001637-88-DK
(EUCTR)
12/08/201424/06/2014Effects on muscle function, in persons with McArdle disease, when treated with the drug Valproate.A phase 2a study to explore treatment with Sodium Valproate in adults with McArdle Disease (Glycogen Storage Disorder Type V, GSDV) - Valproate treatment in McArdle disease McArdle disease (Glycogen storage disorder type V)
MedDRA version: 17.0;Level: LLT;Classification code 10026969;Term: McArdle's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Deprakine
INN or Proposed INN: SODIUM VALPROATE
John VissingNULLNot RecruitingFemale: yes
Male: yes
15Phase 2Denmark
3EUCTR2012-002933-12-GB
(EUCTR)
07/04/201404/04/2014A Phase II Pilot Study to Assess Safety and Efficacy of Sodium Valproate in Adults with McArdle DiseaseA Phase II pilot study to explore treatment with Sodium Valproate in Adults with McArdle Disease (Glycogen Storage Disorder Type V, GSDV) - Sodium Valproate for GSDV Version 1.0 13th January 2014 McArdle disease (Glycogen storage disease type V, GSDV). The condition is an inherited disorder of skeletal muscle that causes exercise intolerance. The condition can give way to potential rhabdomyolysis which can cause acute renal failure and from middle age muscle wasting and weakness. Affected patients are unable to produce lactate during ischaemic exercise due to a congenital lack of the enzyme muscle glycogen phosphorylase which is essential for glycogen metabolism.
MedDRA version: 16.1;Level: LLT;Classification code 10026969;Term: McArdle's disease;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Epilim Chrono 200 Controlled Released tablets
Product Name: Epilim Chrono 200 Controlled Released tablets
INN or Proposed INN: Sodium valproate
Other descriptive name: Valproic acid
Trade Name: Epilim Chrono 300 Controlled Released tablets
Product Name: Epilim Chrono 300 Controlled Released tablets
INN or Proposed INN: Sodium valproate
Other descriptive name: valproic acid
Trade Name: Epilim Chrono 500 Controlled Released tablets
Product Name: Epilim Chrono 500 Controlled Released tablets
INN or Proposed INN: Sodium valproate
Other descriptive name: valproic acid
University College London,NULLNot Recruiting Female: yes
Male: yes
8 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Denmark;United Kingdom