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16
144レノックス・ガストー症候群14
145ウエスト症候群3
156レット症候群7
158結節性硬化症6

140. ドラベ症候群


臨床試験数 : 116 薬物数 : 65 - (DrugBank : 17) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 64
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04485104
(ClinicalTrials.gov)
May 19, 202121/7/2020Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled SeizuresAn Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled SeizuresSeizure in Participants With Tuberous Sclerosis Complex;Seizure in Participants With Dravet Syndrome;Seizure in Participants With Lennox-Gastaut SyndromeDrug: GWP42003-PJazz PharmaceuticalsNULLRecruiting1 Month23 MonthsAll27Phase 3United States
2EUCTR2014-001834-27-NL
(EUCTR)
09/09/201518/06/2015An 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: 20.0;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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
3EUCTR2014-001834-27-FR
(EUCTR)
03/09/201520/07/2015An 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: 18.0;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 LtdNULLNot RecruitingFemale: yes
Male: yes
530Phase 3United States;France;Spain;Poland;Israel;Netherlands;United Kingdom
4EUCTR2014-001834-27-PL
(EUCTR)
18/08/201514/05/2015An 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: 20.0;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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
5NCT02224573
(ClinicalTrials.gov)
June 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
6EUCTR2014-001834-27-ES
(EUCTR)
21/05/201514/04/2015An 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]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
430 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Israel;Netherlands;United Kingdom
7NCT02224703
(ClinicalTrials.gov)
April 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 ControlJazz PharmaceuticalsNULLCompleted2 Years18 YearsAll199Phase 3United States;Australia;Israel;Netherlands;Poland;Spain
8EUCTR2014-002939-34-ES
(EUCTR)
08/04/201516/12/2014A 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: 17.1;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 LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Poland;Spain;Israel;Netherlands;United Kingdom
9NCT02091375
(ClinicalTrials.gov)
March 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 controlJazz PharmaceuticalsNULLCompleted2 Years18 YearsAll120Phase 3United States;France;Poland;United Kingdom
10EUCTR2014-000995-24-PL
(EUCTR)
09/03/201531/10/2014A 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: 18.1;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 LtdNULLNot RecruitingFemale: yes
Male: yes
125France;United States;Poland;United Kingdom
11EUCTR2014-002939-34-NL
(EUCTR)
04/03/201516/03/2015A 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: 20.0;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 LtdNULLNot RecruitingFemale: yes
Male: yes
186Phase 3United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom
12EUCTR2014-001834-27-GB
(EUCTR)
14/01/201530/09/2014An 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: 20.0;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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
680Phase 3France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom
13EUCTR2014-002939-34-GB
(EUCTR)
29/12/201424/09/2014A 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]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Poland;Spain;Israel;Netherlands;United Kingdom
14NCT02091206
(ClinicalTrials.gov)
October 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 DoseJazz PharmaceuticalsNULLCompleted4 Years10 YearsAll34Phase 2United States;United Kingdom
15EUCTR2014-000995-24-GB
(EUCTR)
09/09/201404/07/2014A 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]
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 Recruiting Female: yes
Male: yes
125 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Poland;United Kingdom
16EUCTR2014-002939-34-PL
(EUCTR)
25/01/2016A 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: 20.0;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 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 : 111 薬物数 : 72 - (DrugBank : 14) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 61
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04485104
(ClinicalTrials.gov)
May 19, 202121/7/2020Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled SeizuresAn Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled SeizuresSeizure in Participants With Tuberous Sclerosis Complex;Seizure in Participants With Dravet Syndrome;Seizure in Participants With Lennox-Gastaut SyndromeDrug: GWP42003-PJazz PharmaceuticalsNULLRecruiting1 Month23 MonthsAll27Phase 3United States
2NCT04133480
(ClinicalTrials.gov)
October 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-PJazz PharmaceuticalsNULLWithdrawn3 Years10 YearsAll0Phase 4United States
3EUCTR2014-002941-23-NL
(EUCTR)
30/09/201531/03/2015Study 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: 19.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System 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
4EUCTR2014-001834-27-NL
(EUCTR)
09/09/201518/06/2015An 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: 20.0;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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
5EUCTR2014-001834-27-FR
(EUCTR)
03/09/201520/07/2015An 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: 18.0;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 LtdNULLNot RecruitingFemale: yes
Male: yes
530Phase 3United States;France;Spain;Poland;Israel;Netherlands;United Kingdom
6EUCTR2014-001834-27-PL
(EUCTR)
18/08/201514/05/2015An 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: 20.0;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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
7EUCTR2014-002940-42-GB
(EUCTR)
28/07/201526/09/2014A 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: 18.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System 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
8EUCTR2014-002941-23-PL
(EUCTR)
16/07/201501/04/2015Study 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: 18.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System 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
9NCT02224560
(ClinicalTrials.gov)
June 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 controlJazz PharmaceuticalsNULLCompleted2 Years55 YearsAll225Phase 3United States;France;Spain;United Kingdom
10NCT02224573
(ClinicalTrials.gov)
June 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
11EUCTR2014-001834-27-ES
(EUCTR)
21/05/201514/04/2015An 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]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
430 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Israel;Netherlands;United Kingdom
12NCT02224690
(ClinicalTrials.gov)
April 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: PlaceboJazz PharmaceuticalsNULLCompleted2 Years55 YearsAll171Phase 3United States;Netherlands;Poland
13EUCTR2014-002940-42-ES
(EUCTR)
08/04/201516/12/2014A 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: 17.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System 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
14EUCTR2014-001834-27-GB
(EUCTR)
14/01/201530/09/2014An 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: 20.0;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 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 : 43 薬物数 : 52 - (DrugBank : 15) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 26
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02954887
(ClinicalTrials.gov)
May 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-PJazz PharmaceuticalsNULLCompleted1 Month24 MonthsAll9Phase 3United States;Poland
2NCT02953548
(ClinicalTrials.gov)
April 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-PJazz PharmaceuticalsNULLCompleted1 Month24 MonthsAll9Phase 3United States;Poland
3EUCTR2015-004904-50-PL
(EUCTR)
04/04/2017Phase 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]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: Cannabidiol
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
202 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Poland;Italy;United Kingdom

156. レット症候群


臨床試験数 : 44 薬物数 : 61 - (DrugBank : 23) / 標的遺伝子数 : 57 - 標的パスウェイ数 : 83
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001605-24-IT
(EUCTR)
02/11/202021/01/2021An 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 - NA 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]
Trade Name: CBD soluzione orale nota come Epidyolex e con tale nome è stato approvato in UE
Product Name: Cannabidiolo
Product Code: [GWP42003-P]
INN or Proposed INN: cannabidiolo
Other descriptive name: cannabidiol
GW RESEARCH LTD.NULLNAFemale: yes
Male: no
252Phase 3United States;Canada;Spain;Australia;United Kingdom;Italy
2EUCTR2019-001605-24-ES
(EUCTR)
04/03/202021/02/2020An 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]
Trade Name: 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 LtdNULLNot RecruitingFemale: yes
Male: no
252Phase 3United States;Canada;Spain;Australia;United Kingdom;Italy
3NCT04252586
(ClinicalTrials.gov)
February 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 LtdNULLTerminated2 Years18 YearsAll21Phase 3United States;Australia;Canada;Italy;Spain;United Kingdom
4EUCTR2019-001605-24-GB
(EUCTR)
15/01/202023/10/2019An 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: 20.0;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]
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
5EUCTR2018-003370-27-IT
(EUCTR)
18/09/201924/05/2021A 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. - Not applicable 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]
Trade Name: CBD - Solution Orale, conosciuto come Epidiolex, questo è il nome approvato negli Stati Uniti
Product Name: Cannabidiolo (CBD)
Product Code: [GWP42003-P]
INN or Proposed INN: Cannabidiolo
Other descriptive name: Cannabidiol
GW RESEARCH LTD.NULLNot RecruitingFemale: yes
Male: no
252Phase 3United States;Canada;Spain;Germany;United Kingdom;Italy
6NCT03848832
(ClinicalTrials.gov)
July 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: PlaceboJazz PharmaceuticalsNULLTerminated2 Years18 YearsAll29Phase 3United States;Italy;Spain;United Kingdom
7EUCTR2018-003370-27-GB
(EUCTR)
09/04/201924/12/2018A 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: 20.0;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]
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 : 112 薬物数 : 71 - (DrugBank : 19) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04485104
(ClinicalTrials.gov)
May 19, 202121/7/2020Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled SeizuresAn Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled SeizuresSeizure in Participants With Tuberous Sclerosis Complex;Seizure in Participants With Dravet Syndrome;Seizure in Participants With Lennox-Gastaut SyndromeDrug: GWP42003-PJazz PharmaceuticalsNULLRecruiting1 Month23 MonthsAll27Phase 3United States
2EUCTR2015-002154-12-NL
(EUCTR)
01/09/201717/01/2017A 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]
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.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Spain;Poland;Australia;Netherlands;United Kingdom
3EUCTR2015-002154-12-ES
(EUCTR)
30/09/201615/07/2016A 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: 19.0;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]
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
192Phase 3United States;France;Poland;Spain;Australia;Netherlands;United Kingdom
4NCT02544763
(ClinicalTrials.gov)
April 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: PlaceboJazz PharmaceuticalsNULLCompleted1 Year65 YearsAll224Phase 3United States;Australia;Netherlands;Poland;Spain;United Kingdom
5EUCTR2020-002132-67-Outside-EU/EEA
(EUCTR)
22/10/2021Safety, Pharmacokinetics, and Exploratory Efficacy Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared With Standard of Care Antiseizure Medication, 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 Antiseizure Medication, in Patients Age 1 Month to Less than 12 Months of Age with Tuberous Sclerosis Complex who Experience Inadequately-Controlled SeizuresP/0047/2020P/0350/2020P/0033/2021 Tuberous Sclerosis Complex (TSC)
MedDRA version: 21.0;Level: LLT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: PT;Classification code 10080584;Term: Tuberous sclerosis complex;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Cannabidiol Oral Solution, is known as Epidyolex 100 mg/mL oral solution and is the approved name in the EU. Epidiolex (cannabidiol) oral solution is the approved name in the US.
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
GW Research LtdNULLNAFemale: yes
Male: yes
Phase 3United States
6EUCTR2015-002154-12-PL
(EUCTR)
18/11/2016A 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: 21.0;Level: LLT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: CBD - Oral Solution, is known as Epidyolex 100 mg/ml oral solution,
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
210Phase 3United States;Spain;Poland;Australia;Netherlands;United Kingdom