158. Tuberous sclerosis Clinical trials / Disease details
Clinical trials : 108 / Drugs : 67 - (DrugBank : 17) / Drug target genes : 35 - Drug target pathways : 118
| 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 | NCT05044819 (ClinicalTrials.gov) | July 7, 2021 | 30/8/2021 | Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution | A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution | Lennox Gastaut Syndrome;Dravet Syndrome;Tuberous Sclerosis Complex | Drug: Cannabidiol | GW Research Ltd | NULL | Recruiting | 1 Year | N/A | All | 150 | Phase 4 | United States |
| 2 | NCT04485104 (ClinicalTrials.gov) | May 19, 2021 | 21/7/2020 | Safety, Pharmacokinetics, and Exploratory Efficacy Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared With Standard of Care Antiseizure Medication, in Participants 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 Antiseizure Medication, 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: SOC | GW Research Ltd | NULL | Recruiting | 1 Month | 11 Months | All | 12 | Phase 3 | United States |
| 3 | 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] | 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 | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Spain;Poland;Australia;Netherlands;United Kingdom | ||
| 4 | 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 | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;France;Poland;Spain;Australia;Netherlands;United Kingdom | ||
| 5 | 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 | Completed | 1 Year | 65 Years | All | 224 | Phase 3 | United States |
| 6 | 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 |
| 7 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Spain;Poland;Australia;Netherlands;United Kingdom | |||
| 8 | EUCTR2020-002132-67-Outside-EU/EEA (EUCTR) | 22/10/2021 | Safety, 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 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 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 Ltd | NULL | NA | Female: yes Male: yes | Phase 3 | United States |