Cannabidiol (CBD) ( DrugBank: Cannabidiol )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病3
13多発性硬化症/視神経脊髄炎4
140ドラベ症候群12
144レノックス・ガストー症候群10
145ウエスト症候群1
156レット症候群3
158結節性硬化症4

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003623-37-GB
(EUCTR)
12/02/202002/01/2020CANnabidiol for Parkinson’s Disease PsychosisCANnabidiol for Parkinson’s Disease Psychosis - CAN-PDP Parkinson's disease psychosis
MedDRA version: 20.0;Level: PT;Classification code 10074835;Term: Parkinson's disease psychosis;System Organ Class: 10037175 - Psychiatric disorders;Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
Product Name: Cannabidiol
Product Code: Cannabidiol
INN or Proposed INN: Cannabidiol (CBD)
King's College LondonSouth London and Maudsley NHS Foundation TrustAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United Kingdom
2NCT03582137
(ClinicalTrials.gov)
September 17, 201817/4/2018A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's DiseaseParkinson DiseaseDrug: Cannabidiol;Other: PlaceboUniversity of Colorado, DenverColorado Department of Public Health and EnvironmentCompleted40 Years85 YearsAll74Phase 2United States
3NCT02818777
(ClinicalTrials.gov)
October 20166/5/2016A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's DiseaseParkinson's DiseaseDrug: cannabidiolUniversity of Colorado, DenverColorado Department of Public Health and Environment;GW Research LtdCompleted40 Years80 YearsAll13Phase 2United States

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05269628
(ClinicalTrials.gov)
March 25, 202213/2/2022Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain PhenotypeMechanisms of Cannabidiol (CBD) in Persons With Multiple Sclerosis (MS): the Role of Sleep and Pain PhenotypeMultiple Sclerosis;Sleep;PainDrug: Cannabidiol (CBD);Drug: Tetrahydrocannabinol (THC);Drug: Placebo CBD;Drug: Placebo THCTiffany J. Braley, MD, MSNational Center for Complementary and Integrative Health (NCCIH)Recruiting18 Years65 YearsAll166Phase 2United States
2NCT01610687
(ClinicalTrials.gov)
July 200131/5/2012A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisA Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple Sclerosis;SpasticityDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll137Phase 3United Kingdom
3NCT01610700
(ClinicalTrials.gov)
May 200131/5/2012An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis PatientsDouble Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple SclerosisDrug: GW-1000-02;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll160Phase 3United Kingdom
4NCT01610713
(ClinicalTrials.gov)
May 200131/5/2012An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisDouble Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple SclerosisDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll154Phase 3United Kingdom

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
1NCT02815540
(ClinicalTrials.gov)
February 16, 201720/6/2016The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe EpilepsyThe Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in ChildrenLennox-Gastaut Syndrome;Dravet SyndromeProcedure: 12-Lead ECG;Drug: CannabidiolGillette Children's Specialty HealthcareNULLTerminated2 Years30 YearsAll2Phase 1/Phase 2United 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
5EUCTR2014-001834-27-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
6EUCTR2014-002939-34-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
7EUCTR2014-000995-24-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
8EUCTR2014-002939-34-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
9EUCTR2014-001834-27-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
10EUCTR2014-002939-34-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
11EUCTR2014-000995-24-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
12EUCTR2014-002939-34-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
1NCT02815540
(ClinicalTrials.gov)
February 16, 201720/6/2016The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe EpilepsyThe Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in ChildrenLennox-Gastaut Syndrome;Dravet SyndromeProcedure: 12-Lead ECG;Drug: CannabidiolGillette Children's Specialty HealthcareNULLTerminated2 Years30 YearsAll2Phase 1/Phase 2United States
2EUCTR2014-002941-23-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
3EUCTR2014-001834-27-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
4EUCTR2014-001834-27-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
5EUCTR2014-001834-27-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
6EUCTR2014-002940-42-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
7EUCTR2014-002941-23-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
8EUCTR2014-001834-27-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
9EUCTR2014-002940-42-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
10EUCTR2014-001834-27-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
1EUCTR2015-004904-50-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-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
2EUCTR2019-001605-24-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
3EUCTR2018-003370-27-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
1EUCTR2015-002154-12-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
2EUCTR2015-002154-12-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
3EUCTR2020-002132-67-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
4EUCTR2015-002154-12-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