PMID- 20944074
OWN - NLM
STAT- MEDLINE
DCOM- 20101214
LR  - 20191210
IS  - 1526-632X (Electronic)
IS  - 0028-3878 (Linking)
VI  - 75
IP  - 20
DP  - 2010 Nov 16
TI  - Efficacy and safety of adjunctive ezogabine (retigabine) in refractory partial 
      epilepsy.
PG  - 1817-24
LID - 10.1212/WNL.0b013e3181fd6170 [doi]
AB  - OBJECTIVE: This study assessed the efficacy and safety of the neuronal potassium 
      channel opener ezogabine (US adopted name; EZG)/retigabine (international 
      nonproprietary name; RTG) as adjunctive therapy for refractory partial-onset 
      seizures. METHODS: This was a multicenter, randomized, double-blind, 
      placebo-controlled trial in adults with >/=4 partial-onset seizures per month 
      receiving 1 to 3 antiepileptic drugs. EZG (RTG) or placebo, 3 times daily, was 
      titrated to 600 or 900 mg/d over 4 weeks, and continued during a 12-week 
      maintenance phase. Median percentage seizure reductions from baseline and 
      responder rates (>/=50% reduction in baseline seizure frequency) were assessed. 
      RESULTS: The intention-to-treat population comprised 538 patients (placebo, n = 
      179; 600 mg, n = 181; 900 mg, n = 178), 471 of whom (placebo, n = 164; 600 mg, n 
      = 158; 900 mg, n = 149) entered the maintenance phase. Median percentage seizure 
      reductions were greater in EZG (RTG)-treated patients (600 mg, 27.9%, p = 0.007; 
      900 mg, 39.9%, p < 0.001) compared with placebo (15.9%). Responder rates were 
      higher in EZG (RTG)-treated patients (600 mg, 38.6%, p < 0.001; 900 mg, 47.0%, p 
      < 0.001) than with placebo (18.9%). Treatment discontinuations due to adverse 
      events (AEs) were more likely with EZG (RTG) than with placebo (placebo, 8%; 600 
      mg, 17%, 900 mg, 26%). The most commonly reported (>10%) AEs in the placebo, EZG 
      (RTG) 600 mg/d, and EZG (RTG) 900 mg/d groups were dizziness (7%, 17%, 26%), 
      somnolence (10%, 14%, 26%), headache (15%, 11%, 17%), and fatigue (3%, 15%, 17%). 
      CONCLUSIONS: In this dose-ranging, placebo-controlled trial, adjunctive EZG (RTG) 
      was effective and generally well tolerated in adults with refractory 
      partial-onset seizures. CLASSIFICATION OF EVIDENCE: This study provides Class II 
      evidence that adjunctive EZG/RTG reduces the occurrence of partial-onset 
      seizures.
FAU - Brodie, M J
AU  - Brodie MJ
AD  - Epilepsy Unit, Western Infirmary, Glasgow, Scotland, UK. mjb2k@clinmed.gla.ac.uk
FAU - Lerche, H
AU  - Lerche H
FAU - Gil-Nagel, A
AU  - Gil-Nagel A
FAU - Elger, C
AU  - Elger C
FAU - Hall, S
AU  - Hall S
FAU - Shin, P
AU  - Shin P
FAU - Nohria, V
AU  - Nohria V
FAU - Mansbach, H
AU  - Mansbach H
CN  - RESTORE 2 Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20101013
PL  - United States
TA  - Neurology
JT  - Neurology
JID - 0401060
RN  - 0 (Anticonvulsants)
RN  - 0 (Carbamates)
RN  - 0 (Phenylenediamines)
RN  - 12G01I6BBU (ezogabine)
SB  - IM
MH  - Adult
MH  - Anticonvulsants/*administration & dosage/adverse effects
MH  - Carbamates/administration & dosage/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Epilepsies, Partial/diagnosis/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Outcome Assessment, Health Care
MH  - Phenylenediamines/administration & dosage/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Treatment Outcome
EDAT- 2010/10/15 06:00
MHDA- 2010/12/16 06:00
CRDT- 2010/10/15 06:00
PHST- 2010/10/15 06:00 [entrez]
PHST- 2010/10/15 06:00 [pubmed]
PHST- 2010/12/16 06:00 [medline]
AID - WNL.0b013e3181fd6170 [pii]
AID - 10.1212/WNL.0b013e3181fd6170 [doi]
PST - ppublish
SO  - Neurology. 2010 Nov 16;75(20):1817-24. doi: 10.1212/WNL.0b013e3181fd6170. Epub 
      2010 Oct 13.