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.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04485104 (ClinicalTrials.gov) | September 2020 | 21/7/2020 | Safety, 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 Seizures | An 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 Seizures | Seizure in Participants With Tuberous Sclerosis Complex | Drug: GWP42003-P;Drug: Standard of care | GW Research Ltd | NULL | Not yet recruiting | 1 Month | 11 Months | All | 15 | Phase 3 | NULL |
| 2 | EUCTR2015-002154-12-NL (EUCTR) | 01/09/2017 | 17/01/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Poland;Spain;Australia;Netherlands;United Kingdom | |||
| 3 | EUCTR2015-002154-12-ES (EUCTR) | 30/09/2016 | 15/07/2016 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | France;United States;Spain;Australia;United Kingdom | ||
| 4 | NCT02544750 (ClinicalTrials.gov) | August 2016 | 7/9/2015 | An 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 Seizures | Tuberous Sclerosis Complex;Seizures | Drug: GWP42003-P | GW Research Ltd | NULL | Enrolling by invitation | 1 Year | 65 Years | All | 210 | Phase 3 | United States |
| 5 | NCT02544763 (ClinicalTrials.gov) | April 6, 2016 | 7/9/2015 | A 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 Seizures | Tuberous Sclerosis Complex;Seizures | Drug: GWP42003-P;Drug: Placebo | GW Research Ltd | NULL | Completed | 1 Year | 65 Years | All | 224 | Phase 3 | United States;Australia;Netherlands;Poland;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2015-002154-12-PL (EUCTR) | 18/11/2016 | A 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 Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd. | NULL | NA | Female: yes Male: yes | 210 | Phase 3 | United States;Spain;Poland;Australia;Netherlands;United Kingdom |