PMID- 19832771
OWN - NLM
STAT- MEDLINE
DCOM- 20091117
LR  - 20220316
IS  - 1600-0404 (Electronic)
IS  - 0001-6314 (Linking)
VI  - 120
IP  - 5
DP  - 2009 Nov
TI  - Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive 
      treatment in adults with refractory partial-onset seizures.
PG  - 281-7
LID - 10.1111/j.1600-0404.2009.01218.x [doi]
AB  - OBJECTIVES: To evaluate the efficacy and safety of eslicarbazepine acetate (ESL) 
      as adjunctive therapy in adults with partial-onset seizures. MATERIAL AND 
      METHODS: Double-blind, placebo-controlled, parallel-group, multicenter study 
      consisting of an 8-week baseline period, after which patients were randomized to 
      placebo (n = 87) or once-daily ESL 800 mg (n = 85) or 1200 mg (n = 80). Patients 
      received half dose during 2 weeks preceding a 12-week maintenance period. 
      RESULTS: Seizure frequency over the maintenance period was significantly (P < 
      0.05) lower than placebo in both ESL groups. Responder rate was 23% (placebo), 
      35% (800 mg), and 38% (1200 mg). Median relative reduction in seizure frequency 
      was 17% (placebo), 38% (800 mg), and 42% (1200 mg). The most common adverse 
      events (AEs) (>10%) were dizziness, somnolence, headache, and nausea. The 
      majority of AEs were of mild or moderate severity. CONCLUSIONS: Once-daily 
      treatment with ESL 800 and 1200 mg was effective and generally well tolerated.
FAU - Gil-Nagel, A
AU  - Gil-Nagel A
AD  - Hospital Ruber Internacional, Mirasierra, Madrid, Spain.
FAU - Lopes-Lima, J
AU  - Lopes-Lima J
FAU - Almeida, L
AU  - Almeida L
FAU - Maia, J
AU  - Maia J
FAU - Soares-da-Silva, P
AU  - Soares-da-Silva P
CN  - BIA-2093-303 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
PL  - Denmark
TA  - Acta Neurol Scand
JT  - Acta neurologica Scandinavica
JID - 0370336
RN  - 0 (Anticonvulsants)
RN  - 0 (Dibenzazepines)
RN  - 0 (Placebos)
RN  - BEA68ZVB2K (eslicarbazepine acetate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Anticonvulsants/administration & dosage/adverse effects/therapeutic use
MH  - Dibenzazepines/*administration & dosage/*adverse effects/*therapeutic use
MH  - Dizziness/chemically induced
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Epilepsies, Partial/*drug therapy
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Patient Selection
MH  - Placebos
MH  - Seizures/drug therapy
MH  - Treatment Outcome
FIR - Diaz Torres, Marco Antonio
IR  - Diaz Torres MA
FIR - Hoyos Gomez, Leticia
IR  - Hoyos Gomez L
FIR - Jimenez Ponce, Fiacro
IR  - Jimenez Ponce F
FIR - Ojeda Chavarria, Manuel
IR  - Ojeda Chavarria M
FIR - Oropeza De-Alba, Jose-Luis
IR  - Oropeza De-Alba JL
FIR - Quinones, Sandra
IR  - Quinones S
FIR - Ramos, Ricardo
IR  - Ramos R
FIR - Rangel-Guerra, Ricardo
IR  - Rangel-Guerra R
FIR - Rivera Nava, Silvia Cristina
IR  - Rivera Nava SC
FIR - Rodriguez, Jeronimo
IR  - Rodriguez J
FIR - Vasquez, Rosalia
IR  - Vasquez R
FIR - de Almeida, Luis Bigotte
IR  - de Almeida LB
FIR - Chorao, Rui
IR  - Chorao R
FIR - de Sousa, Georgina
IR  - de Sousa G
FIR - Alves, Manuel Dilio
IR  - Alves MD
FIR - Lima, Jose Lopes
IR  - Lima JL
FIR - Lourenco, Esmeralda
IR  - Lourenco E
FIR - Luzeiro, Isabel
IR  - Luzeiro I
FIR - Martins, Antonio
IR  - Martins A
FIR - Martins, Fernando
IR  - Martins F
FIR - Pereira, Henrique
IR  - Pereira H
FIR - Marques, Jose Pinto
IR  - Marques JP
FIR - Santos, Ana Paula
IR  - Santos AP
FIR - Branco, Jose Vieira
IR  - Branco JV
FIR - Asensio, Montserrat
IR  - Asensio M
FIR - Astriazaran, Francisco
IR  - Astriazaran F
FIR - Bertol, Vicente
IR  - Bertol V
FIR - Fernandez, Oscar
IR  - Fernandez O
FIR - Garcia-Monco, Juan Carlos
IR  - Garcia-Monco JC
FIR - Gil-Nagel, Antonio
IR  - Gil-Nagel A
FIR - Maldonado, Rafael Gonzelez
IR  - Maldonado RG
FIR - Mauri, Jose Angel
IR  - Mauri JA
FIR - Molins, Alberto
IR  - Molins A
FIR - Morales, Maria Dolores
IR  - Morales MD
FIR - Navarro, Ricardo
IR  - Navarro R
FIR - Serratosa, Jose Maria
IR  - Serratosa JM
FIR - Tejada, Javier
IR  - Tejada J
FIR - Vilchez, Juan Jesus
IR  - Vilchez JJ
FIR - Villalobos, Francisco
IR  - Villalobos F
EDAT- 2009/10/17 06:00
MHDA- 2009/11/18 06:00
CRDT- 2009/10/17 06:00
PHST- 2009/10/17 06:00 [entrez]
PHST- 2009/10/17 06:00 [pubmed]
PHST- 2009/11/18 06:00 [medline]
AID - ANE1218 [pii]
AID - 10.1111/j.1600-0404.2009.01218.x [doi]
PST - ppublish
SO  - Acta Neurol Scand. 2009 Nov;120(5):281-7. doi: 10.1111/j.1600-0404.2009.01218.x.