RETIGABINE ( DrugBank: Retigabine )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症2
144レノックス・ガストー症候群4

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001431-20-NL
(EUCTR)
17/08/201521/04/2015Trial to look at the nerve conductance in patients with ALS, with and without Riluzole or Retigabine.A randomized, double blind, double-dummy placebo controlled, 3-way cross-over study to determine the test-retest reliability of, and the effect of oral retigabine and riluzole on, peripheral motor nerve excitability measurements in patients with ALS. - Peripheral motor nerve excitability study in patients with ALS Amytrophic Lateral Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rilutek 50 mg film-coated tablets
Product Name: Rilutek
INN or Proposed INN: RILUZOLE
Trade Name: Trobalt
Product Name: Trobalt
INN or Proposed INN: RETIGABINE
Centre for Human Drug ResearchNULLNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
2NCT02450552
(ClinicalTrials.gov)
June 201519/5/2015Clinical Trial of Ezogabine (Retigabine) in ALS SubjectsA Phase 2 Pharmacodynamic Trial of Ezogabine (Retigabine) on Neuronal Excitability in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Ezogabine;Drug: PlaceboBrian WaingerALS Association;GlaxoSmithKline;Harvard University;Massachusetts General HospitalCompleted18 Years80 YearsAll65Phase 2United States

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
2NCT01494584
(ClinicalTrials.gov)
July 25, 20121/12/2011Study in Pediatric Subjects With EpilepsyOpen-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 SyndromeEpilepsyDrug: ezogabine/retigabineGlaxoSmithKlineBausch Health Americas, Inc.Terminated12 Years17 YearsAll5Phase 2United 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
4EUCTR2012-001132-60-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