156. レット症候群 Rett syndrome Clinical trials / Disease details
臨床試験数 : 40 / 薬物数 : 53 - (DrugBank : 19) / 標的遺伝子数 : 77 - 標的パスウェイ数 : 113
| 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 | EUCTR2019-001605-24-IT (EUCTR) | 02/11/2020 | 21/01/2021 | An open label extension study for long-term safety of GWP42003-P in patients with Rett Syndrome | An 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. | NULL | NA | Female: yes Male: no | 252 | Phase 3 | United States;Canada;Spain;Australia;United Kingdom;Italy | ||
| 2 | EUCTR2019-001605-24-ES (EUCTR) | 04/03/2020 | 21/02/2020 | An open label extension study for long-term safety of GWP42003-P in patients with Rett Syndrome | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: no | 252 | Phase 3 | United States;Canada;Spain;Australia;United Kingdom;Italy | ||
| 3 | NCT04252586 (ClinicalTrials.gov) | February 28, 2020 | 30/1/2020 | An Open-label Extension Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome | An 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 | Drug: GWP42003-P | GW Research Ltd | NULL | Terminated | 2 Years | 18 Years | All | 21 | Phase 3 | United States;Australia;Canada;Italy;Spain;United Kingdom |
| 4 | EUCTR2019-001605-24-GB (EUCTR) | 15/01/2020 | 23/10/2019 | An open label extension study for long-term safety of GWP42003-P in patients with Rett Syndrome | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 3 | United States;France;Canada;Spain;Australia;Italy;United Kingdom | ||
| 5 | EUCTR2018-003370-27-IT (EUCTR) | 18/09/2019 | 24/05/2021 | 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. | 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. | NULL | Not Recruiting | Female: yes Male: no | 252 | Phase 3 | United States;Canada;Spain;Germany;United Kingdom;Italy | ||
| 6 | NCT03848832 (ClinicalTrials.gov) | July 29, 2019 | 19/2/2019 | 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 | Drug: GWP42003-P;Drug: Placebo | GW Research Ltd | NULL | Terminated | 2 Years | 18 Years | Female | 252 | Phase 3 | United States;Italy;Spain;United Kingdom |
| 7 | EUCTR2018-003370-27-GB (EUCTR) | 09/04/2019 | 24/12/2018 | 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. | 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2;Phase 3 | United States;France;Canada;Spain;Australia;Italy;United Kingdom |