Epidyolex ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 156 | レット症候群 | 4 |
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. | 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 | 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 | ||
| 4 | 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 |