Gwp42003-p    (DrugBank: -)

5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
140ドラベ症候群15
144レノックス・ガストー症候群13
145ウエスト症候群3
156レット症候群5
158結節性硬化症6

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.
15 / 83 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-001834-27-NL09/09/201518/06/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
2EUCTR2014-001834-27-FR03/09/201520/07/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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: 18.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
530Phase 3United States;France;Spain;Poland;Israel;Netherlands;United Kingdom
3EUCTR2014-001834-27-PL18/08/201514/05/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
4NCT02224573June 201521/8/2014GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut SyndromesAn 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 SyndromeDrug: GWP42003-PGW Research LtdNULLCompleted2 YearsN/AAll681Phase 3NULL
5EUCTR2014-001834-27-ES21/05/201514/04/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot Recruiting Female: yes
Male: yes
430 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Poland;Spain;Israel;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02224703April 13, 201521/8/2014GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet SyndromeA 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 SyndromeDrug: GWP42003-P;Drug: Placebo ControlGW Research LtdNULLCompleted2 Years18 YearsAll199Phase 3United States;Australia;Israel;Netherlands;Poland;Spain
7EUCTR2014-002939-34-ES08/04/201516/12/2014A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 17.1Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Poland;Spain;Israel;Netherlands;United Kingdom
8NCT02091375March 30, 201517/3/2014Antiepileptic 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 SyndromeEpilepsy;Dravet SyndromeDrug: GWP42003-P 20 mg/kg/day Dose;Drug: Placebo controlGW Research LtdNULLCompleted2 Years18 YearsAll120Phase 3United States;France;Poland;United Kingdom
9EUCTR2014-000995-24-PL09/03/201531/10/2014A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 18.1Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
125France;United States;Poland;United Kingdom
10EUCTR2014-002939-34-NL04/03/201516/03/2015A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
186Phase 3United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2014-001834-27-GB14/01/201530/09/2014An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
680Phase 3France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom
12EUCTR2014-002939-34-GB29/12/201424/09/2014A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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 LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Poland;Spain;Israel;Netherlands;United Kingdom
13NCT02091206October 22, 201417/3/2014A 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 SyndromeEpilepsy;Dravet SyndromeDrug: 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 DoseGW Research LtdNULLCompleted4 Years10 YearsAll34Phase 2United States;United Kingdom
14EUCTR2014-000995-24-GB09/09/201404/07/2014A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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 LtdNULLNot Recruiting Female: yes
Male: yes
125 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Poland;United Kingdom
15EUCTR2014-002939-34-PL25/01/2016A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
186Phase 3United States;Spain;Poland;Australia;Israel;Netherlands;United Kingdom

144. レノックス・ガストー症候群 [臨床試験数:80,薬物数:63(DrugBank:11),標的遺伝子数:49,標的パスウェイ数:59
Searched query = "Lennox-Gastaut 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.
13 / 80 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04133480October 202017/10/2019Investigation of Cognitive Outcomes With Cannabidiol Oral SolutionAn Open-Label Exploratory Investigation of Cognitive Outcomes With Cannabidiol Oral Solution (EPIDIOLEX®; GWP42003-P)Lennox-Gastaut SyndromeDrug: GWP42003-PGW Research LtdNULLWithdrawn3 Years10 YearsAll0Phase 4United States
2EUCTR2014-002941-23-NL30/09/201531/03/2015Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures associated with Lennox-Gastaut Syndrome in children and adultsA randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox- Gastaut syndrome in children and adults Lennox-Gastaut syndrome
MedDRA version: 19.0Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system 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.NULLNot RecruitingFemale: yes
Male: yes
100United States;Poland;Netherlands
3EUCTR2014-001834-27-NL09/09/201518/06/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
4EUCTR2014-001834-27-FR03/09/201520/07/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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: 18.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
530Phase 3United States;France;Spain;Poland;Israel;Netherlands;United Kingdom
5EUCTR2014-001834-27-PL18/08/201514/05/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2014-002940-42-GB28/07/201526/09/2014A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and AdultsA randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults. Lennox-Gastaut syndrome (LGS)
MedDRA version: 18.0Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system 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 LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;United States;Spain;United Kingdom
7EUCTR2014-002941-23-PL16/07/201501/04/2015Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures associated with Lennox-Gastaut Syndrome in children and adultsA randomized, double-blind, placebo-controlled study toinvestigate the efficacy and safety of cannabidiol (GWP42003-P;CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults Lennox-Gastaut syndrome
MedDRA version: 18.1Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system 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.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Poland;Netherlands
8NCT02224560June 8, 201521/8/2014Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and AdultsA Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults.Epilepsy;Lennox Gastaut SyndromeDrug: GWP42003-P;Drug: Placebo controlGW Research LtdNULLCompleted2 Years55 YearsAll225Phase 3United States;France;Spain;United Kingdom
9NCT02224573June 201521/8/2014GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut SyndromesAn 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 SyndromeDrug: GWP42003-PGW Research LtdNULLCompleted2 YearsN/AAll681Phase 3NULL
10EUCTR2014-001834-27-ES21/05/201514/04/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot Recruiting Female: yes
Male: yes
430 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Poland;Spain;Israel;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02224690April 28, 201521/8/2014A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and AdultsA Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults.Epilepsy;Lennox-Gastaut SyndromeDrug: GWP42003-P 20 mg/kg/day Dose;Drug: PlaceboGW Research LtdNULLCompleted2 Years55 YearsAll171Phase 3United States;Netherlands;Poland
12EUCTR2014-002940-42-ES08/04/201516/12/2014A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and AdultsA randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults. Lennox-Gastaut syndrome (LGS)
MedDRA version: 17.1Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system 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 LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;United Kingdom
13EUCTR2014-001834-27-GB14/01/201530/09/2014An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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: 20.0Level: PTClassification code 10073677Term: Severe myoclonic epilepsy of infancySystem 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
680Phase 3France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom

145. ウエスト症候群 [臨床試験数:39,薬物数:50(DrugBank:13),標的遺伝子数:27,標的パスウェイ数:24
Searched query = "West syndrome", "Infantile spasm"
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.
3 / 39 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02954887May 12, 20172/11/2016Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot StudyInfantile SpasmsDrug: GWP42003-PGW Research LtdNULLCompleted1 Month24 MonthsAll9Phase 3United States;Poland
2NCT02953548April 24, 20171/11/2016Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot StudyInfantile SpasmsDrug: GWP42003-PGW Research LtdNULLCompleted1 Month24 MonthsAll9Phase 3United States;Poland
3EUCTR2015-004904-50-PL04/04/2017Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile SpasmsA randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Cannabidiol (GWP42003-P) in infants with Infantile Spasms following an initial open label pilot study. Infantile Spasms
MedDRA version: 20.1 Level: PT Classification code 10021750 Term: Infantile spasms System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
202 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Hungary;Poland;Italy;United Kingdom

156. レット症候群 [臨床試験数:36,薬物数:49(DrugBank:19),標的遺伝子数:77,標的パスウェイ数:112
Searched query = "Rett 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.
5 / 36 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1EUCTR2019-001605-24-ES04/03/202021/02/2020An open label extension study for long-term safety of GWP42003-P in patients with Rett SyndromeAn open-label extension trial to investigate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in patients with Rett Syndrome Rett syndrome (RTT) [typical or atypical]
MedDRA version: 20.0 Level: PT Classification code 10077709 Term: Rett syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
GW Research LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: no
252 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Canada;Spain;Australia;Italy;United Kingdom
2NCT04252586February 28, 202030/1/2020An Open-label Extension Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeAn Open-label Extension Trial to Investigate the Long-term Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeRett Syndrome;RTTDrug: GWP42003-PGW Research LtdNULLEnrolling by invitation2 Years18 YearsAll252Phase 3United States;Australia;Canada;Italy;Spain;United Kingdom
3EUCTR2019-001605-24-GB15/01/202023/10/2019An open label extension study for long-term safety of GWP42003-P in patients with Rett SyndromeAn open-label extension trial to investigate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in patients with Rett Syndrome Rett syndrome (RTT) [typical or atypical]
MedDRA version: 20.0Level: PTClassification code 10077709Term: Rett syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: CBD Oral solution, is known as Epidyolex and is the approved name in the EU
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: Cannabidiol
Other descriptive name: CANNABIDIOL
GW Research LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 3United States;France;Canada;Spain;Australia;Italy;United Kingdom
4NCT03848832July 29, 201919/2/2019Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeA Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeRett Syndrome;RTTDrug: GWP42003-P;Drug: PlaceboGW Research LtdNULLActive, not recruiting2 Years18 YearsFemale252Phase 3United States;Italy;Spain;United Kingdom
5EUCTR2018-003370-27-GB09/04/201924/12/2018A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett syndrome.A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett syndrome. Rett syndrome (RTT) [typical or atypical]
MedDRA version: 20.0Level: PTClassification code 10077709Term: Rett syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: CBD - Oral Solution, is known as Epidyolex, and is the approved name
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: Cannabidiol
Other descriptive name: CANNABIDIOL
GW Research LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2;Phase 3United States;France;Canada;Spain;Australia;Italy;United Kingdom

158. 結節性硬化症 [臨床試験数:100,薬物数:62(DrugBank:16),標的遺伝子数:35,標的パスウェイ数:115
Searched query = "Tuberous sclerosis", "Tuberous sclerosis complex"
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.
6 / 100 trials found
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04485104September 202021/7/2020Safety, Pharmacokinetics, and Exploratory Efficacy Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared With Standard of Care Antiepileptic Therapy, in Patients Age 1 Month to <12 Months of Age With Tuberous Sclerosis Complex Who Experience Inadequately-controlled SeizuresAn Open-label, Randomized Trial to Assess the Safety, Pharmacokinetics, and Exploratory Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared With Standard of Care Antiepileptic Therapy, in Patients Age 1 Month to Less Than 12 Months of Age With Tuberous Sclerosis Complex Who Experience Inadequately-controlled SeizuresSeizure in Participants With Tuberous Sclerosis ComplexDrug: GWP42003-P;Drug: Standard of careGW Research LtdNULLNot yet recruiting1 Month11 MonthsAll15Phase 3NULL
2EUCTR2015-002154-12-NL01/09/201717/01/2017A study of cannabidiol (GWP42003-P, CBD) in patients with tuberous sclerosis complex who experience seizures.A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures Tuberous Sclerosis Complex (TSC)
MedDRA version: 20.0 Level: PT Classification code 10045138 Term: Tuberous sclerosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
GW Research Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Poland;Spain;Australia;Netherlands;United Kingdom
3EUCTR2015-002154-12-ES30/09/201615/07/2016A study of cannabidiol (GWP42003-P, CBD) in patients with tuberous sclerosis complex who experience seizures.A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures Tuberous Sclerosis Complex (TSC)
MedDRA version: 19.0Level: PTClassification code 10045138Term: Tuberous sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3France;United States;Spain;Australia;United Kingdom
4NCT02544750August 20167/9/2015An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled SeizuresTuberous Sclerosis Complex;SeizuresDrug: GWP42003-PGW Research LtdNULLEnrolling by invitation1 Year65 YearsAll210Phase 3United States
5NCT02544763April 6, 20167/9/2015A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled SeizuresTuberous Sclerosis Complex;SeizuresDrug: GWP42003-P;Drug: PlaceboGW Research LtdNULLCompleted1 Year65 YearsAll224Phase 3United States;Australia;Netherlands;Poland;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-002154-12-PL18/11/2016A study of cannabidiol (GWP42003-P, CBD) in patients with tuberous sclerosis complex who experience seizures.A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures Tuberous Sclerosis Complex (TSC)
MedDRA version: 21.0Level: LLTClassification code 10045138Term: Tuberous sclerosisSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
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.NULLNAFemale: yes
Male: yes
210Phase 3United States;Spain;Poland;Australia;Netherlands;United Kingdom