PMID- 19243424
OWN - NLM
STAT- MEDLINE
DCOM- 20090413
LR  - 20220316
IS  - 1528-1167 (Electronic)
IS  - 0013-9580 (Linking)
VI  - 50
IP  - 3
DP  - 2009 Mar
TI  - Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults 
      with refractory partial-onset seizures: a randomized, double-blind, 
      placebo-controlled, parallel-group phase III study.
PG  - 454-63
LID - 10.1111/j.1528-1167.2008.01946.x [doi]
AB  - PURPOSE: To study the efficacy and safety of eslicarbazepine acetate (ESL) as 
      adjunctive therapy for refractory partial seizures in adults with >or=4 
      partial-onset seizures (simple or complex, with or without secondary 
      generalization) per 4 weeks despite treatment with 1-2 antiepileptic drugs 
      (AEDs). METHODS: This multicenter, parallel-group study had an 8-week, 
      single-blind, placebo baseline phase, after which patients were randomized to 
      placebo (n = 102) or once-daily ESL 400 mg (n = 100), 800 mg (n = 98), or 1,200 
      mg (n = 102) in the double-blind treatment phase. ESL starting dose was 400 mg; 
      thereafter, ESL was titrated at weekly 400-mg steps to the full maintenance dose 
      (12 weeks). RESULTS: Seizure frequency adjusted per 4 weeks over the maintenance 
      period (primary endpoint) was significantly lower than placebo in the ESL 
      1,200-mg (p = 0.0003) and 800-mg (p = 0.0028) groups [analysis of covariance 
      (ANCOVA) of log-transformed seizure frequency]. Responder rate was 20% (placebo), 
      23% (400 mg), 34% (800 mg), and 43% (1,200 mg). Median relative reduction in 
      seizure frequency was 16% (placebo), 26% (400 mg), 36% (800 mg), and 45% (1,200 
      mg). The most frequent concomitant AEDs were carbamazepine (56-62% of patients), 
      lamotrigine (25-27%), and valproic acid (22-28%). Similar efficacy results were 
      obtained in patients administered ESL with or without carbamazepine as 
      concomitant AED. Discontinuation rates caused by adverse events (AEs) were 3.9% 
      (placebo), 4% (400 mg), 8.2% (800 mg), and 19.6% (1,200 mg). AEs in >10% of any 
      group were dizziness, headache, and diplopia. Most AEs were mild or moderate. 
      DISCUSSION: ESL, 800 and 1,200 mg once-daily, was well tolerated and more 
      effective than placebo in patients who were refractory to treatment with one or 
      two concomitant AEDs.
FAU - Elger, Christian
AU  - Elger C
AD  - Department of Epileptology, University of Bonn, Bonn, Germany.
FAU - Halasz, Peter
AU  - Halasz P
FAU - Maia, Joana
AU  - Maia J
FAU - Almeida, Luis
AU  - Almeida L
FAU - Soares-da-Silva, Patricio
AU  - Soares-da-Silva P
CN  - BIA-2093-301 Investigators Study Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090221
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Anticonvulsants)
RN  - 0 (Dibenzazepines)
RN  - BEA68ZVB2K (eslicarbazepine acetate)
SB  - IM
CIN - Epilepsy Curr. 2010 Jan;10(1):7-8. PMID: 20126330
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Anticonvulsants/adverse effects/pharmacokinetics/*therapeutic use
MH  - Dibenzazepines/adverse effects/pharmacokinetics/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Synergism
MH  - Drug Therapy, Combination
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Epilepsies, Partial/blood/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Metabolic Clearance Rate/physiology
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2009/02/27 09:00
MHDA- 2009/04/14 09:00
CRDT- 2009/02/27 09:00
PHST- 2009/02/27 09:00 [entrez]
PHST- 2009/02/27 09:00 [pubmed]
PHST- 2009/04/14 09:00 [medline]
AID - EPI1946 [pii]
AID - 10.1111/j.1528-1167.2008.01946.x [doi]
PST - ppublish
SO  - Epilepsia. 2009 Mar;50(3):454-63. doi: 10.1111/j.1528-1167.2008.01946.x. Epub 
      2009 Feb 21.