144. レノックス・ガストー症候群 Lennox-Gastaut syndrome Clinical trials / Disease details
臨床試験数 : 111 / 薬物数 : 72 - (DrugBank : 14) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 61
| 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 | NCT01668654 (ClinicalTrials.gov) | September 4, 2012 | 17/5/2012 | Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS | RTG113388, a Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects With Partial Onset Seizures (>= 12 Years Old) and Subjects With Lennox-Gastaut Syndrome (>=12 Years Old) | Epilepsy | Drug: retigabine/ezogabine | GlaxoSmithKline | Bausch Health Americas, Inc. | Terminated | 12 Years | 29 Years | All | 4 | Phase 3 | United States |
| 2 | NCT01494584 (ClinicalTrials.gov) | July 25, 2012 | 1/12/2011 | Study in Pediatric Subjects With Epilepsy | Open-label, Multiple Dose Study to Evaluate the Parmacokinetics, Safety and Tolerability of Ezogabine/Retigabine as Adjunctive Treatment in Subjects Aged From 12 Years to Less Than 18 Years With Partial Onset Seizures or Lennox-Gastaut Syndrome | Epilepsy | Drug: ezogabine/retigabine | GlaxoSmithKline | Bausch Health Americas, Inc. | Terminated | 12 Years | 17 Years | All | 5 | Phase 2 | United States |
| 3 | EUCTR2012-001132-60-Outside-EU/EEA (EUCTR) | 09/03/2012 | Study in pediatric subjects with epilepsy | Open-label, multiple dose study to evaluate thepharmacokinetics, safety and tolerability of ezogabine/retigabineas adjunctive treatment in subjects aged from 12 years to lessthan 18 years with partial onset seizures or Lennox-Gastautsyndrome | Uncontrolled partial onset seizures or Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10061334;Term: Partial seizures;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Potiga Product Name: Retigabine/Ezogabine Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Product Name: Retigabine/Ezogabine INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Product Name: Retigabine/Ezogabine INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) | GlaxoSmithKline R&D Limited | NULL | NA | Female: yes Male: yes | 16 | United States | ||||
| 4 | EUCTR2010-020154-33-Outside-EU/EEA (EUCTR) | 09/03/2012 | Long-term Open-label Evaluation of Retigabine in Pediatric Subjects with Epilepsy | RTG113388, a Long-term, Open-label Safety Extension Study ofRetigabine/Ezogabine in Pediatric Subjects with Partial OnsetSeizures(=12 years old) and Subjects with Lennox-GastautSyndrome (=12 years old) - Long-term Open-label Safety Extension Study of Retigabine/Ezogabine in subjects >=12yrs with POS/LGS | Uncontrolled partial onset seizures or Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10061334;Term: Partial seizures;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Trade Name: Potiga Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US only) Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) | GlaxoSmithKline R&D Limited | NULL | NA | Female: yes Male: yes | 500 | United States |