Valproic Acid ( DrugBank: Valproic acid )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
3脊髄性筋萎縮症8
5進行性核上性麻痺1
26HTLV-1関連脊髄症1
65原発性免疫不全症候群1
90網膜色素変性症3
222一次性ネフローゼ症候群1
256筋型糖原病1

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
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size
PhaseCountries
1JPRN-JMA-IIA00259
16/08/201610/08/2016Multicenter cooperative and investigator initiated clinical trial using valproic acid in childhood onset spinal muscular atrophy : Continuous administration trialMulticenter cooperative and investigator initiated clinical trial using valproic acid in childhood onset spinal muscular atrophy : Continuous administration trial spinal muscular atrophyIntervention type:DRUG. Intervention1:SMART, Dose form:GRANULES, Route of administration:ORAL, intended dose regimen:VPA 12.5mg/kg or 25mg/kg is to be taken once a day after supper..Institute of Medical Genetics, Tokyo Women's Medical UniversityNULLRecruiting>=1 YEARS<8 YEARSBOTH28Phase 2BJapan
2JPRN-JMA-IIA00231
29/01/201601/12/2015Multicenter cooperative and investigator initiated clinical trial using valproic acid in childhood onset spinal muscular atrophy : Confirmatory TrialMulticenter cooperative and investigator initiated clinical trial using valproic acid in childhood onset spinal muscular atrophy : Confirmatory Trial spinal muscular atrophyIntervention type:DRUG. Intervention1:SMART, Dose form:GRANULES, Route of administration:ORAL, intended dose regimen:VPA 12.5mg/kg or 25mg/kg is to be taken once a day after supper.. Control intervention1:Placebo, Dose form:GRANULES, Route of administration:ORAL, Intended dose regimen:Placebo is to be taken once a day after supper..Institute of Medical Genetics, Tokyo Women's Medical UniversityNULLCompleted>=1 YEARS<7 YEARSBOTH28Phase 2BJapan
3JPRN-JMA-IIA00190
22/07/201401/08/2014Multicenter cooperative and investigator initiated clinical trial using valproic acid in childhood onset spinal muscular atrophyMulticenter cooperative and investigator initiated clinical trial using valproic acid in childhood onset spinal muscular atrophy spinal muscular atrophyIntervention type:DRUG. Intervention1:SMART, Dose form:GRANULES, Route of administration:ORAL, intended dose regimen:VPA is to be taken once a day after supper.
Administration of VPA starts with an initial dosage (standard dose: 12.5 mg / kg) for 4 weeks.
The dosage then increases to a maintenance dosage (standard dose: 25 mg/kg) from the 5th week to the 12th week. Administration, however, could be increased to an additional 50 mg/day in case of a blood concentration of VPA below 50 mcg/mL
From the 13th week, administered doses are to be decreased (standard dose: 12.5 mg/kg) and continued to the 14th week. . Control intervention1:No.
Institute of Medical Genetics, Tokyo Women's Medical UniversityNULLCompletedNo Limit<8 YEARSBOTH13Phase 2AJapan
4EUCTR2008-003915-11-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
5NCT00661453
(ClinicalTrials.gov)
April 200814/4/2008CARNIVAL Type I: Valproic Acid and Carnitine in Infants With Spinal Muscular Atrophy (SMA) Type IPhase I/II Trial of Valproic Acid and Carnitine in Infants With Spinal Muscular Atrophy Type I (CARNI-VAL Type I)Spinal Muscular Atrophy Type IDrug: Valproic Acid and LevocarnitineUniversity of UtahFamilies of Spinal Muscular Atrophy;Leadiant Biosciences, Inc.CompletedN/A12 MonthsAll40Phase 1/Phase 2United States;Canada;Germany
6NCT00481013
(ClinicalTrials.gov)
July 200730/5/2007Valproic Acid in Ambulant Adults With Spinal Muscular AtrophyProspective Controlled Trial of Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy (VALIANTSMA) StudySpinal Muscular AtrophyDrug: Valproic Acid (VPA);Drug: PlaceboUniversity of UtahFamilies of Spinal Muscular Atrophy;AbbottCompleted18 Years60 YearsBoth33Phase 2United States
7NCT00227266
(ClinicalTrials.gov)
September 200523/9/2005Valproic Acid and Carnitine in Patients With Spinal Muscular AtrophyMulti-center Phase II Trial of Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy (SMA CARNI-VAL Trial)Spinal Muscular AtrophyDrug: Valproic Acid and Levocarnitine;Drug: PlaceboUniversity of UtahFamilies of Spinal Muscular Atrophy;Leadiant Biosciences, Inc.;AbbottCompleted2 Years17 YearsAll94Phase 2United States;Canada
8NCT00374075
(ClinicalTrials.gov)
September 20036/9/2006Study of Safety and Dosing Effect on SMN Levels of Valproic Acid (VPA) in Patients With Spinal Muscular AtrophyIn Vivo Study of Safety, Tolerability and Dosing Effect on SMN mRNA and Protein Levels of Valproic Acid in Patients With Spinal Muscular AtrophySpinal Muscular AtrophyDrug: Valproic AcidUniversity of UtahFamilies of Spinal Muscular Atrophy;Sigma Tau Pharmaceuticals, Inc.;AbbottCompleted2 YearsN/ABoth42Phase 1United States

5. 進行性核上性麻痺


臨床試験数 : 89 薬物数 : 107 - (DrugBank : 40) / 標的遺伝子数 : 65 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00385710
(ClinicalTrials.gov)
November 200610/10/2006Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine)Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: valproic acid;Drug: PlaceboNantes University HospitalNULLCompleted45 Years75 YearsBoth28Phase 2France

26. HTLV-1関連脊髄症


臨床試験数 : 29 薬物数 : 47 - (DrugBank : 29) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 119
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00681980
(ClinicalTrials.gov)
February 200819/5/2008Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, BrazilParaparesis Spastic TropicalDrug: Valproic acid;Drug: costicosteroids;Drug: valproid acid plus corticosteroidsUniversity of Sao PauloNULLCompleted18 Years70 YearsBoth60Phase 3Brazil

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00605657
(ClinicalTrials.gov)
January 200815/1/2008Valproic Acid (Depakote[Registered Trademark]) to Treat Autoimmune Lymphoproliferative Syndrome (ALPS)Pilot (Phase I-II) Study of Valproic Acid (Depakote) for the Treatment of the Autoimmune Lymphoproliferative Syndrome (ALPS)ALPS;Hypersplenism;LymphadenopathyDrug: Valproic Acid;Procedure: CT Scan;Procedure: Blood SampleKoneti RaoNULLCompleted2 Years70 YearsAll6Phase 1/Phase 2United States

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
1NCT01399515
(ClinicalTrials.gov)
March 20113/5/2011Efficacy and Safety of Oral Valproic Acid for Retinitis PigmentosaRetinitis Pigmentosa;Retinal Diseases;Eye Diseases;Eye Disease, Hereditary;Retinal DegenerationDrug: Valproic AcidSeoul National University HospitalNULLCompleted18 YearsN/ABoth200Phase 2Korea, Republic of
2JPRN-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
3NCT01233609
(ClinicalTrials.gov)
November 20101/11/2010Trial of Oral Valproic Acid for Retinitis PigmentosaA Phase II Multiple Site, Randomized, Placebo-Controlled Trial of Oral Valproic Acid for Autosomal Dominant Retinitis PigmentosaRetinitis PigmentosaDrug: Valproic Acid;Drug: PlaceboFoundation Fighting Blindness Clinical Research InstituteUnited States Department of DefenseCompleted18 YearsN/AAll90Phase 2United States

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02896270
(ClinicalTrials.gov)
October 20166/9/2016Valproic Acid for Idiopathic Nephrotic SyndromeA Prospective Interventional Pilot Study on the Use of Valproic Acid for Treatment of Idiopathic Nephrotic SyndromeIdiopathic Nephrotic Syndrome;Focal Segmental Glomerulosclerosis;Minimal Change DiseaseDrug: Valproic AcidUniversitair Ziekenhuis BrusselNULLRecruiting18 YearsN/AAll15Phase 2/Phase 3Belgium

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
1EUCTR2012-002933-12-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