140. ドラベ症候群 ［臨床試験数：34，薬物数：27（DrugBank：8），標的遺伝子数：42，標的パスウェイ数：53］
Searched query = "Dorabe syndrome", "Dravet syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04069689 | August 29, 2019 | 30 September 2019 | Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects. | A Phase I, Placebo-Controlled, Double-Blind, 2-Period Study to Assess Safety and Pharmacokinetics of Escalating Single and Multiple Oral Doses of EPX-100 in Fasting Healthy Subjects and Following a High-Fat Meal | Dravet Syndrome | Drug: EPX-100 (Clemizole Hydrochloride);Drug: Placebos | Epygenix | Recruiting | 18 Years | 50 Years | All | 24 | Phase 1 | United States | |
| 2 | NCT03936777 | April 22, 2019 | 24 June 2019 | A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients With Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome;Epileptic Encephalopathy | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix, Inc. | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Recruiting | 2 Years | N/A | All | 650 | Phase 3 | United States |
| 3 | NCT03650452 | August 8, 2018 | 4 November 2019 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome | Drug: TAK-935;Drug: Placebo | Takeda | Ovid Therapeutics Inc. | Recruiting | 2 Years | 17 Years | All | 126 | Phase 2 | United States;Australia;Canada;China;Israel;Poland;Portugal;Spain |
| 4 | NCT03635073 | July 19, 2018 | 22 October 2019 | A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy | A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy | Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorder | Drug: TAK-935 | Takeda | Ovid Therapeutics Inc. | Recruiting | 2 Years | 65 Years | All | 176 | Phase 2 | United States;Australia;China;Israel;Poland;Spain |
| 5 | NCT03780127 | April 15, 2018 | 2 September 2019 | ZX008 Expanded Access Protocol | ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan | Dravet Syndrome | Drug: Fenfluramine Hydrochloride | Zogenix, Inc. | Not recruiting | 2 Years | N/A | All | Phase 1 | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03254680 | March 2018 | 11 June 2018 | Turmeric as Treatment in Epilepsy | Turmeric as Treatment in Epilepsy | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome;Tuberous Sclerosis;Focal Seizures | Dietary Supplement: Turmeric | New York University School of Medicine | Not recruiting | 1 Year | 70 Years | All | 0 | N/A | United States | |
| 7 | NCT03467113 | January 19, 2018 | 30 September 2019 | A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With DS or LGS Currently Taking CBD | An Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: ZX008 0.2 and 0.8 mg/kg/day | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Not recruiting | 2 Years | 18 Years | All | 25 | Phase 1/Phase 2 | United States | |
| 8 | NCT02318563 | December 30, 2017 | 18 January 2018 | Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome | A Multicenter, Randomized, Double-blind, Placebo- Controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Dravet Syndrome | Dravet Syndrome | Drug: Cannabidiol Oral Solution;Drug: Placebo Solution | INSYS Therapeutics Inc | Not recruiting | 1 Year | 30 Years | All | 0 | Phase 3 | ||
| 9 | NCT03299842 | August 23, 2017 | 24 June 2019 | A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome | An Exploratory, Pilot Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome: A Sub-study to the ZX008-1503 Open-Label Extension Trial | Dravet Syndrome | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Recruiting | N/A | N/A | All | 20 | Phase 3 | United States | |
| 10 | NCT02815540 | February 16, 2017 | 11 March 2019 | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children | Lennox-Gastaut Syndrome;Dravet Syndrome | Drug: Cannabidiol;Procedure: 12-Lead ECG | Gillette Children's Specialty Healthcare | Not recruiting | 2 Years | 30 Years | All | 2 | Phase 1/Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT02758626 | November 2016 | 10 December 2018 | Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome | A Phase 2 Randomized, Double-Masked Placebo-Controlled Crossover Safety and Tolerability Study of Ataluren for Drug Resistant Epilepsy in Patients With Nonsense Mutation CDKL5 or Dravet Syndrome | Epilepsy | Drug: ataluren;Drug: Placebo | New York University School of Medicine | PTC Therapeutics | Not recruiting | 2 Years | 12 Years | All | 16 | Phase 2 | United States |
| 12 | EUCTR2016-000474-38-NL | 13/09/2016 | 20 August 2018 | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) | Dravet's syndrome MedDRA version: 18.1 Level: LLT Classification code 10073682 Term: Dravet syndrome System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 Pharmaceutical Form: Oral solution INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE CAS Number: 404-82-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.25- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: Fenfluramine hydrochloride Product Code: ZX008 Pharmaceutical Form: Oral solution INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE CAS Number: 404-82-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: Fenfluramine hydrochloride Product Code: ZX008 Pharmaceutical Form: Oral solution INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE CAS Number: 404-82-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | Zogenix International Limited | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Spain;Germany;Netherlands;United Kingdom | |||
| 13 | NCT02926898 | September 2016 | 24 June 2019 | A Two-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children =2 Years Old and Young Adults With Dravet Syndrome | A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care , Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults With Dravet Syndrome | Dravet Syndrome | Drug: ZX008 - 0.2 mg/kg/day;Drug: ZX008 - 0.4 mg/kg/day;Drug: ZX008 - 20 mg/day maximum dose;Drug: Matching Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Not recruiting | 2 Years | 18 Years | All | 105 | Phase 3 | United States;Canada;France;Germany;Netherlands;Spain;United Kingdom | |
| 14 | NCT02826863 | July 15, 2016 | 30 September 2019 | A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | Dravet Syndrome | Drug: ZX008 - 0.8 mg/kg/day;Drug: ZX008 - 0.2 mg/kg/day;Drug: Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Recruiting | 2 Years | 18 Years | All | 130 | Phase 3 | Australia;Belgium;Denmark;France;Germany;Italy;Japan;Spain;United Kingdom;Norway;Sweden | |
| 15 | NCT02823145 | June 2016 | 30 September 2019 | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome | An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | Dravet Syndrome | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Recruiting | 2 Years | 35 Years | All | 340 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Spain;United Kingdom;Norway;Sweden | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2015-004167-37-GB | 17/05/2016 | 21 July 2016 | Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome | Dravet's syndrome MedDRA version: 19.0 Level: LLT Classification code 10073682 Term: Dravet syndrome System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fenfluramine hydrochloride Product Code: ZX008 Pharmaceutical Form: Oral solution INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE CAS Number: 404-82-0 Current Sponsor code: ZX008 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.25- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: Fenfluramine hydrochloride Product Code: ZX008 Pharmaceutical Form: Oral solution INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE CAS Number: 404-82-0 Current Sponsor code: ZX008 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: Fenfluramine hydrochloride Product Code: ZX008 Pharmaceutical Form: Oral solution INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE CAS Number: 404-82-0 Current Sponsor code: ZX008 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | Zogenix International Limited | Authorised | Female: yes Male: yes | 260 | Phase 3 | France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;Switzerland;United Kingdom;Sweden | |||
| 17 | NCT02682927 | January 2016 | 30 September 2019 | A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome | Dravet Syndrome;Seizure Disorder | Drug: ZX008 (Fenfluramine Hydrochloride);Drug: Matching Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Not recruiting | 2 Years | 18 Years | All | 130 | Phase 3 | United States;Canada | |
| 18 | NCT02224573 | June 2015 | 17 June 2019 | GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut Syndromes | An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes. | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome | Drug: GWP42003-P | GW Research Ltd | Not recruiting | 2 Years | N/A | All | 681 | Phase 3 | ||
| 19 | NCT02091375 | March 2015 | 10 October 2016 | Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1) | A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome | Epilepsy;Dravet Syndrome | Drug: GWP42003-P;Drug: Placebo control | GW Research Ltd | Not recruiting | 2 Years | 18 Years | Both | 120 | Phase 3 | United States | |
| 20 | NCT02174094 | March 2015 | 6 October 2015 | Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Multi-site, Prospective, Randomised, Double-blind, Placebo-controlled, Parallel-group, Interventional Study to Evaluate the Efficacy, Safety, and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Dravet Syndrome | Drug: Clobazam;Drug: Placebo | H. Lundbeck A/S | Not recruiting | 1 Year | 16 Years | Both | 0 | Phase 3 | United States;Mexico | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT02187809 | March 2015 | 16 December 2017 | Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Multi-site, Prospective, Open-label, Long-term, Flexible Dose, Interventional Study to Evaluate the Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Dravet Syndrome | Drug: Clobazam | H. Lundbeck A/S | Not recruiting | 1 Year | 16 Years | All | 3 | Phase 3 | United States;Mexico | |
| 22 | NCT02224703 | March 2015 | 24 October 2016 | GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome | A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome. | Epilepsy;Dravet Syndrome | Drug: GWP42003-P;Drug: Placebo Control | GW Research Ltd | Recruiting | 2 Years | 18 Years | Both | 150 | Phase 3 | United States;Netherlands | |
| 23 | NCT02091206 | October 2014 | 10 October 2016 | A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1) | A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome | Epilepsy;Dravet Syndrome | Drug: GWP42003-P;Drug: Placebo control | GW Research Ltd | Not recruiting | 4 Years | 10 Years | Both | 34 | Phase 2 | United States | |
| 24 | EUCTR2014-000995-24-GB | 09/09/2014 | 10 April 2017 | A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A double-blind, placebo-controlled two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet Syndrome MedDRA version: 18.0 Level: PT Classification code 10073677 Term: Severe myoclonic epilepsy of infancy System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P Pharmaceutical Form: Oral solution INN or Proposed INN: N/A CAS Number: 13956-29-1 Current Sponsor code: GWP42003-P Other descriptive name: CANNABIDIOL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: Cannabidiol (CBD) Product Code: GWP42003-P Pharmaceutical Form: Oral solution INN or Proposed INN: N/A CAS Number: 13956-29-1 Current Sponsor code: GWP42003-P Other descriptive name: CANNABIDIOL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | GW Research Ltd | Not Recruiting | Female: yes Male: yes | 125 | Phase 2;Phase 3 | France;United States;Poland;United Kingdom | |||
| 25 | NCT01983722 | February 2014 | 22 July 2019 | Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome | Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome | Dravet Syndrome | Drug: Stiripentol | Children's Hospital Medical Center, Cincinnati | Not recruiting | 6 Months | N/A | All | Phase 1 | United States | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT01835314 | July 8, 2013 | 14 October 2019 | Compassionate Use of Stiripentol in Dravet Syndrome | Compassionate Use of Stiripentol in Dravet Syndrome | Dravet Syndrome | Drug: Stiripentol | University of Colorado, Denver | Not recruiting | 1 Year | 21 Years | All | Phase 2 | United States | ||
| 27 | NCT01607073 | April 2012 | 7 April 2015 | Verapamil as Therapy for Children and Young Adults With Dravet Syndrome | Verapamil as Adjunctive Seizure Therapy for Children and Young Adults With Dravet Syndrome | Dravet Syndrome | Drug: Verapamil | Beverly S. Wical, M.D. | Dartmouth-Hitchcock Medical Center;Mayo Clinic;Ann & Robert H Lurie Children's Hospital of Chicago | Not recruiting | 2 Years | 25 Years | Both | 2 | Phase 2 | United States |
| 28 | NCT01533506 | February 2012 | 19 February 2015 | Stiripentol in Dravet Syndrome | Compassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet Syndrome | Dravet Syndrome | Drug: stiripentol | Mayo Clinic | Not recruiting | 11 Years | N/A | Female | Phase 4 | United States | ||
| 29 | NCT02239276 | March 2011 | 11 February 2019 | Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies | Expanded Access Use of Stiripentol in Participants With Dravet Syndrome or Epileptic Encephalopathies Associated With Sodium Channel Mutations | Dravet Syndrome;Epileptic Encephalopathies Associated With SCN1A Mutations | Drug: Stiripentol | M. Scott Perry | Not recruiting | 6 Months | 18 Years | All | Phase 2 | United States | ||
| 30 | JPRN-JapicCTI-101116 | 01/4/2010 | 23 April 2019 | Open Phase III Study of ME2080 in Patients with Dravet Syndrome | Open Phase III Study of ME2080 in Patients with Dravet Syndrome | Dravet Syndrome | Intervention name : ME2080 (stiripentol) Dosage And administration of the intervention : 50mg/kg/day administered twice or 3 times a day (maximum 2500mg/day) | Meiji Seika Pharma Co., Ltd. (formerly MEIJI SEIKA KAISHA Co., LTD.) | 1 | 30 | BOTH | 25 | Phase 3 | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | JPRN-JMA-IIA00014 | 01/10/2007 | 2 April 2019 | Use of the antiepileptic drug stiripentol for the treatment of severe myoclonic epilepsy in infancy (SMEI) | Clinical evaluation of stiripentol in Dravet syndrome | Dravet syndrome (severe myoclonic epilepsy in infancy: SMEI) | Intervention type:DRUG. Intervention1:Stiripentol, Dose form:FINE GRANULES, Route of administration:ORAL, intended dose regimen:Stiripentol will be started at 50 mg/kg (or 1000 mg for patients weighing 20 kg or more) and will be titrated up to 100 mg/kg (maximum of 4.0 g).. | Yushi Inoue National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders | Shunya Ikeda Department of Pharmaceutical Sciences, International University of Health and Welfare Yoko Ohtsuka Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Hirokazu Oguni Department of Pediatrics, Tokyo Women's Medical University Yukitoshi Takahashi National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders Jun Tohyama National Hospital Organization Nishi-Niigata Chuo National Hospital Hiroshi Baba National Hospital Organization Nagasaki Medical Center Katsuyuki Fukushima National Hospital Organization Yakumo Hospital | Not Recruiting | >=1 YEARS | BOTH | 10 | NOT APPLICABLE | Japan | |
| 32 | EUCTR2007-001784-30-FR | 19/07/2007 | 19 March 2012 | Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study. | Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study. | Antiepileptic | Trade Name: DIACOMIT Product Name: DIACOMIT Pharmaceutical Form: Capsule, hard Trade Name: DIACOMIT Product Name: DIACOMIT Pharmaceutical Form: Powder for oral suspension | BIOCODEX | Authorised | Female: yes Male: yes | France | |||||
| 33 | EUCTR2007-002198-30-IT | 03/07/2007 | 17 February 2014 | A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDY | A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDY | Dravet Syndrome MedDRA version: 14.1 Level: PT Classification code 10054859 Term: Myoclonic epilepsy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: stiripentolo Pharmaceutical Form: Capsule, hard INN or Proposed INN: Other antiepileptics Concentration unit: mg milligram(s) Concentration number: 250- Trade Name: TOPAMAX Pharmaceutical Form: Capsule, hard INN or Proposed INN: Topiramate Concentration unit: mg milligram(s) Concentration number: 25- Trade Name: FRISIUM*30CPS 10MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Clobazam Concentration unit: mg milligram(s) Concentration number: 10- | Inserm-ISP Pole Recherches cliniques et thérapeutiques | Not Recruiting | Female: yes Male: yes | 90 | Italy | ||||
| 34 | EUCTR2007-003702-95-IT | 03/07/2007 | 17 February 2014 | A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY - ND | A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY - ND | Dravet Syndrome Level: PT Classification code 10054859 | Trade Name: stiripentolo Pharmaceutical Form: Capsule, hard Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Trade Name: TOPAMAX Pharmaceutical Form: Capsule, hard INN or Proposed INN: Topiramate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: FRISIUM*30CPS 10MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Clobazam Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | ISTITUTO C. MONDINO | Authorised | Female: yes Male: yes | 90 | Italy |