158. 結節性硬化症 Tuberous sclerosis Clinical trials / Disease details


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

  
7 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05044819
(ClinicalTrials.gov)
July 7, 202130/8/2021Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionA Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionLennox Gastaut Syndrome;Dravet Syndrome;Tuberous Sclerosis ComplexDrug: CannabidiolJazz PharmaceuticalsNULLRecruiting1 YearN/AAll150Phase 4United States
2NCT04485104
(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
3EUCTR2015-002154-12-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
4EUCTR2015-002154-12-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
5NCT02544763
(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
6EUCTR2020-002132-67-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
7EUCTR2015-002154-12-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