PMID- 17420403
OWN - NLM
STAT- MEDLINE
DCOM- 20070501
LR  - 20130501
IS  - 1526-632X (Electronic)
IS  - 0028-3878 (Linking)
VI  - 68
IP  - 15
DP  - 2007 Apr 10
TI  - Randomized, multicenter, dose-ranging trial of retigabine for partial-onset 
      seizures.
PG  - 1197-204
AB  - OBJECTIVE: To evaluate the efficacy and safety of retigabine 600, 900, and 1,200 
      mg/day administered three times daily as adjunctive therapy in patients with 
      partial-onset seizures. METHODS: A multicenter, randomized, double-blind, 
      placebo-controlled trial was performed. After an 8-week baseline phase, patients 
      were randomized to a 16-week double-blind treatment period (8-week forced 
      titration and 8-week maintenance) followed by either tapering or entry into an 
      open-label extension study. Primary efficacy was the percentage change from 
      baseline in monthly seizure frequency and compared across treatment arms. 
      Secondary efficacy comparisons included the proportion of patients experiencing 
      >/=50% reduction in seizure frequency (responder rate), emergence of new seizure 
      types, and physician assessment of global clinical improvement. 
      Safety/tolerability assessments included adverse events (AEs), physical and 
      neurologic examinations, and clinical laboratory evaluations. Efficacy analyses 
      were performed on the intent-to-treat population. RESULTS: Of the 399 randomized 
      patients, 279 (69.9%) completed the double-blind treatment period. The median 
      percent change in monthly total partial seizure frequency from baseline was -23% 
      for 600 mg/day, -29% for 900 mg/day, and -35% for 1,200 mg/day vs -13% for 
      placebo (p < 0.001 for overall difference across all treatment arms). Responder 
      rates for retigabine were 23% for 600 mg/day, 32% for 900 mg/day (p = 0.021), and 
      33% for 1,200 mg/day (p = 0.016), vs 16% for placebo. The most common 
      treatment-emergent AEs were somnolence, dizziness, confusion, speech disorder, 
      vertigo, tremor, amnesia, abnormal thinking, abnormal gait, paresthesia, and 
      diplopia. CONCLUSION: Adjunctive therapy with retigabine is well tolerated and 
      reduces the frequency of partial-onset seizures in a dose-dependent manner.
FAU - Porter, R J
AU  - Porter RJ
AD  - University of Pennsylvania, Philadelphia, PA, USA. rjportermd@aol.com
FAU - Partiot, A
AU  - Partiot A
FAU - Sachdeo, R
AU  - Sachdeo R
FAU - Nohria, V
AU  - Nohria V
FAU - Alves, W M
AU  - Alves WM
CN  - 205 Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Neurology
JT  - Neurology
JID - 0401060
RN  - 0 (Anticonvulsants)
RN  - 0 (Carbamates)
RN  - 0 (Phenylenediamines)
RN  - 12G01I6BBU (ezogabine)
SB  - IM
CIN - Epilepsy Curr. 2007 Nov-Dec;7(6):153-4. PMID: 18049722
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anticonvulsants/administration & dosage/adverse effects
MH  - Australia/epidemiology
MH  - Carbamates/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Epilepsies, Partial/diagnosis/*drug therapy/*epidemiology
MH  - Europe/epidemiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phenylenediamines/*administration & dosage/adverse effects
MH  - Risk Assessment/*methods
MH  - Risk Factors
MH  - Treatment Outcome
MH  - United States/epidemiology
EDAT- 2007/04/11 09:00
MHDA- 2007/05/02 09:00
CRDT- 2007/04/11 09:00
PHST- 2007/04/11 09:00 [pubmed]
PHST- 2007/05/02 09:00 [medline]
PHST- 2007/04/11 09:00 [entrez]
AID - 68/15/1197 [pii]
AID - 10.1212/01.wnl.0000259034.45049.00 [doi]
PST - ppublish
SO  - Neurology. 2007 Apr 10;68(15):1197-204. doi: 10.1212/01.wnl.0000259034.45049.00.