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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03204500 (ClinicalTrials.gov) | May 2016 | 28/6/2017 | Dual 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, Sporadic | Combination Product: Active treatment with dual therapy;Drug: Placebos | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez | NULL | Completed | 40 Years | 70 Years | All | 43 | Phase 2 | Mexico |
| 2 | NCT00136110 (ClinicalTrials.gov) | April 2005 | 24/8/2005 | Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Sequential Clinical Trial of Sodium Valproate in ALS | Amyotrophic Lateral Sclerosis | Drug: Sodium Valproate | UMC Utrecht | Princess Beatrix Fund, The Netherlands | Completed | 18 Years | 85 Years | Both | 165 | Phase 3 | Netherlands |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01671384 (ClinicalTrials.gov) | August 2013 | 13/8/2012 | Valproate and Levocarnitine in Children With Spinal Muscular Atrophy | Randomized Placebo Controlled Trial of Valproate and Levocarnitine in Children With Spinal Muscular Atrophy Aged 2-15 Years | Spinal Muscular Atrophy | Drug: Valproate, Levocarnitine;Drug: Placebo | All India Institute of Medical Sciences, New Delhi | NULL | Recruiting | 2 Years | 15 Years | Both | 60 | Phase 3 | India |
| 2 | EUCTR2008-003915-11-DE (EUCTR) | 24/09/2009 | 25/06/2009 | Phase I/II Trial of Valproic Acid and Carnitine in Infants with Spinal Muscular Atrophy Type I (CARNI-VAL Type I) - CARNI-VAL Type I | Phase 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 Utah | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 1/2 | Germany |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JMA-IIA00053 | 24/12/2010 | 22/11/2010 | Clinical Trial of Therapeutic Effect of Valproic Acid in Retinitis Pigmentosa | Clinical Trial of Therapeutic Effect of Valproic Acid in Retinitis Pigmentosa | Retinitis Pigmentosa | Intervention type:DRUG. Intervention1:Sodium valproate, Dose form:TABLET, Route of administration:ORAL. | Yasuhiko Hirami | Masayo Takahashi, Yasuo Kurimoto | Completed | >=20 YEARS | No Limit | BOTH | 30 | NOT APPLICABLE | Japan |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01619644 (ClinicalTrials.gov) | April 2012 | 12/6/2012 | Rubinstein-Taybi Syndrome: Functional Imaging and Therapeutic Trial | Rubinstein-Taybi Syndrome: Functional Imaging and Therapeutic Trial | Rubinstein-Taybi Syndrome | Drug: sodium valproate;Drug: Placebo | University Hospital, Bordeaux | Fondation Syndrome de Rubinstein-Taybi | Completed | 6 Years | 21 Years | Both | 41 | Phase 2 | France |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04940572 (ClinicalTrials.gov) | November 26, 2021 | 11/5/2021 | Efficacy Study of Daily Administration of VPA in Patients Affected by Wolfram Syndrome | AUDIOWOLF: 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 Syndrome | Drug: Depakine | Centre d'Etude des Cellules Souches | Genethon | Recruiting | 13 Years | N/A | All | 23 | Phase 2 | France |
| 2 | EUCTR2017-001215-37-PL (EUCTR) | 13/02/2020 | 10/10/2019 | 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 200 mg gastro-resistant tablets | University of Birmingham | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | France;Poland;United Kingdom | ||
| 3 | NCT03717909 (ClinicalTrials.gov) | December 28, 2018 | 11/10/2018 | Efficacy and Safety Trial of Sodium Valproate, in Paediatric and Adult Patients With Wolfram Syndrome | A Pivotal, International, Randomised, Double-blind, Efficacy and Safety Trial of Sodium Valproate, in Paediatric and Adult Patients With Wolfram Syndrome | Wolfram Syndrome | Drug: Sodium Valproate 200Mg E/C Tablet;Drug: Sodium Valproate matched placebo | University of Birmingham | NULL | Recruiting | 5 Years | N/A | All | 70 | Phase 2 | France;Poland;Spain;United Kingdom |
| 4 | EUCTR2017-001215-37-GB (EUCTR) | 19/03/2018 | 21/06/2018 | 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 Birmingham | NULL | Authorised-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): no | France;Poland;Spain;United Kingdom | ||
| 5 | EUCTR2020-004594-43-FR (EUCTR) | 11/03/2021 | AUDIOWOLF: 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: 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-Stem | NULL | NA | Female: yes Male: yes | 23 | Phase 2 | France | |||
| 6 | EUCTR2017-001215-37-FR (EUCTR) | 03/02/2020 | 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 Birmingham | NULL | NA | Female: yes Male: yes | 70 | Phase 2 | France;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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03112889 (ClinicalTrials.gov) | January 2015 | 11/8/2015 | Sodium Valproate for GSDV | A 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 Disease | Drug: Sodium Valproate | University College, London | NULL | Completed | 18 Years | 64 Years | All | 8 | Phase 2 | Denmark;United Kingdom |
| 2 | EUCTR2014-001637-88-DK (EUCTR) | 12/08/2014 | 24/06/2014 | Effects 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 Vissing | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Denmark | ||
| 3 | EUCTR2012-002933-12-GB (EUCTR) | 07/04/2014 | 04/04/2014 | A Phase II Pilot Study to Assess Safety and Efficacy of Sodium Valproate in Adults with McArdle Disease | A 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 | ,NULL | Not 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): no | United States;Denmark;United Kingdom |