RETIGABINE/EZOGABINE ( DrugBank: Ezogabine, Retigabine )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
144レノックス・ガストー症候群3

144. レノックス・ガストー症候群


臨床試験数 : 101 薬物数 : 68 - (DrugBank : 12) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 60
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01668654
(ClinicalTrials.gov)
September 4, 201217/5/2012Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGSRTG113388, 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)EpilepsyDrug: retigabine/ezogabineGlaxoSmithKlineBausch Health Americas, Inc.Terminated12 Years29 YearsAll4Phase 3United States
2EUCTR2012-001132-60-Outside-EU/EEA
(EUCTR)
09/03/2012Study in pediatric subjects with epilepsyOpen-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 LimitedNULLNAFemale: yes
Male: yes
16United States
3EUCTR2010-020154-33-Outside-EU/EEA
(EUCTR)
09/03/2012Long-term Open-label Evaluation of Retigabine in Pediatric Subjects with EpilepsyRTG113388, 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 LimitedNULLNAFemale: yes
Male: yes
500United States