140. ドラベ症候群
［臨床試験数：83，薬物数：54（DrugBank：13），標的遺伝子数：48，標的パスウェイ数：62］
Searched query = "Dorabe syndrome", "Dravet syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | NCT04611438 (ClinicalTrials.gov) | March 30, 2020 | 16/9/2019 | Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome | A Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: Cannabidiol | Yonsei University | NULL | Recruiting | 2 Years | 18 Years | All | 107 | Phase 3 | Korea, Republic of |
| 2 | NCT03467113 (ClinicalTrials.gov) | January 19, 2018 | 30/1/2018 | 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. | NULL | Active, not recruiting | 2 Years | 18 Years | All | 25 | Phase 1;Phase 2 | United States |
| 3 | NCT02318563 (ClinicalTrials.gov) | December 30, 2017 | 12/12/2014 | 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Syndrome | Dravet Syndrome | Drug: Cannabidiol Oral Solution;Drug: Placebo Solution | INSYS Therapeutics Inc | NULL | Withdrawn | 1 Year | 30 Years | All | 0 | Phase 3 | NULL |
| 4 | NCT02815540 (ClinicalTrials.gov) | February 16, 2017 | 20/6/2016 | 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 | Procedure: 12-Lead ECG;Drug: Cannabidiol | Gillette Children's Specialty Healthcare | NULL | Terminated | 2 Years | 30 Years | All | 2 | Phase 1;Phase 2 | United States |
| 5 | EUCTR2014-001834-27-NL (EUCTR) | 09/09/2015 | 18/06/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;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] | Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 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 |
| 6 | EUCTR2014-001834-27-FR (EUCTR) | 03/09/2015 | 20/07/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) 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 INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 530 | Phase 3 | United States;France;Spain;Poland;Israel;Netherlands;United Kingdom | ||
| 7 | EUCTR2014-001834-27-PL (EUCTR) | 18/08/2015 | 14/05/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;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] | Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 8 | NCT02224573 (ClinicalTrials.gov) | June 2015 | 21/8/2014 | 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 | NULL | Completed | 2 Years | N/A | All | 681 | Phase 3 | NULL |
| 9 | EUCTR2014-001834-27-ES (EUCTR) | 21/05/2015 | 14/04/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) 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] | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 430 | Phase 3 | France;United States;Poland;Spain;Israel;Netherlands;United Kingdom | |||
| 10 | NCT02224703 (ClinicalTrials.gov) | April 13, 2015 | 21/8/2014 | 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 | NULL | Completed | 2 Years | 18 Years | All | 199 | Phase 3 | United States;Australia;Israel;Netherlands;Poland;Spain |
| 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 |
| 11 | EUCTR2014-002939-34-ES (EUCTR) | 08/04/2015 | 16/12/2014 | A study of the safety and efficacy 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. | Dravet syndrome MedDRA version: 17.1;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 INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;Poland;Spain;Israel;Netherlands;United Kingdom | ||
| 12 | NCT02091375 (ClinicalTrials.gov) | March 30, 2015 | 17/3/2014 | 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 20 mg/kg/day Dose;Drug: Placebo control | GW Research Ltd | NULL | Completed | 2 Years | 18 Years | All | 120 | Phase 3 | United States;France;Poland;United Kingdom |
| 13 | EUCTR2014-000995-24-PL (EUCTR) | 09/03/2015 | 31/10/2014 | 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: 18.1;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 INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 125 | France;United States;Poland;United Kingdom | |||
| 14 | EUCTR2014-002939-34-NL (EUCTR) | 04/03/2015 | 16/03/2015 | A study of the safety and efficacy 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. | Dravet syndrome MedDRA version: 20.0;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 INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom | ||
| 15 | EUCTR2014-001834-27-GB (EUCTR) | 14/01/2015 | 30/09/2014 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;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 INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 680 | Phase 3 | France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom | ||
| 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 |
| 16 | EUCTR2014-002939-34-GB (EUCTR) | 29/12/2014 | 24/09/2014 | A study of the safety and efficacy 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. | Dravet syndrome MedDRA version: 17.0;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] | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;Poland;Spain;Israel;Netherlands;United Kingdom | |||
| 17 | NCT02091206 (ClinicalTrials.gov) | October 22, 2014 | 17/3/2014 | 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 5 mg/kg/day Dose;Drug: Placebo control;Drug: GWP42003-P 10 mg/kg/day Dose;Drug: GWP42003-P 20 mg/kg/day Dose | GW Research Ltd | NULL | Completed | 4 Years | 10 Years | All | 34 | Phase 2 | United States;United Kingdom |
| 18 | EUCTR2014-000995-24-GB (EUCTR) | 09/09/2014 | 04/07/2014 | 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] | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 2;Phase 3 | France;United States;Poland;United Kingdom | |||
| 19 | EUCTR2014-002939-34-PL (EUCTR) | 25/01/2016 | A study of the safety and efficacy 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. | Dravet syndrome MedDRA version: 20.0;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 INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | United States;Spain;Poland;Australia;Israel;Netherlands;United Kingdom |