PMID- 26575256
OWN - NLM
STAT- MEDLINE
DCOM- 20160718
LR  - 20181202
IS  - 1525-5069 (Electronic)
IS  - 1525-5050 (Linking)
VI  - 53
DP  - 2015 Dec
TI  - Severity and burden of partial-onset seizures in a phase III trial of 
      eslicarbazepine acetate.
PG  - 149-53
LID - S1525-5050(15)00533-8 [pii]
LID - 10.1016/j.yebeh.2015.09.018 [doi]
AB  - OBJECTIVE: The objective of this study was to compare posttreatment seizure 
      severity in a phase III clinical trial of eslicarbazepine acetate (ESL) as 
      adjunctive treatment of refractory partial-onset seizures. METHODS: The Seizure 
      Severity Questionnaire (SSQ) was administered at baseline and posttreatment. The 
      SSQ total score (TS) and component scores (frequency and helpfulness of warning 
      signs before seizures [BS]; severity and bothersomeness of ictal movement and 
      altered consciousness during seizures [DS]; cognitive, emotional, and physical 
      aspects of postictal recovery after seizures [AS]; and overall severity and 
      bothersomeness [SB]) were calculated for the per-protocol population. Analysis of 
      covariance, adjusted for baseline scores, estimated differences in posttreatment 
      least square means between treatment arms. RESULTS: Out of 547 per-protocol 
      patients, 441 had valid SSQ TS both at baseline and posttreatment. Mean 
      posttreatment TS for ESL 1200 mg/day was significantly lower than that for 
      placebo (2.68 vs 3.20, p<0.001), exceeding the minimal clinically important 
      difference (MCID: 0.48). Mean DS, AS, and SB were also significantly lower with 
      ESL 1200 mg/day; differences in AS and SB exceeded the MCIDs. The TS, DS, AS, and 
      SB were lower for ESL 800 mg/day than for placebo; only SB was significant 
      (p=0.013). For both ESL arms combined versus placebo, mean scores differed 
      significantly for TS (p=0.006), DS (p=0.031), and SB (p=0.001). CONCLUSIONS: 
      Therapeutic ESL doses led to clinically meaningful, dose-dependent reductions in 
      seizure severity, as measured by SSQ scores. CLASSIFICATION OF EVIDENCE: This 
      study presents Class I evidence that adjunctive ESL (800 and 1200 mg/day) led to 
      clinically meaningful, dose-dependent seizure severity reductions, measured by 
      the SSQ.
CI  - Copyright (c) 2015 Elsevier Inc. All rights reserved.
FAU - Cramer, Joyce A
AU  - Cramer JA
AD  - Department of Medical Research, Health Outcomes, Houston, TX, USA. Electronic 
      address: joyce.cramer@gmail.com.
FAU - Velez, Fulton F
AU  - Velez FF
AD  - Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: 
      Fulton.Velez@sunovion.com.
FAU - Anastassopoulos, Kathryn P
AU  - Anastassopoulos KP
AD  - Covance Market Access Services Inc., Gaithersburg, MD, USA. Electronic address: 
      Kathryn.Anastassopoulos@Covance.com.
FAU - Bond, T Christopher
AU  - Bond TC
AD  - Covance Market Access Services Inc., Gaithersburg, MD, USA. Electronic address: 
      Christopher.Bond@Covance.com.
FAU - Gilliam, Frank G
AU  - Gilliam FG
AD  - Department of Neurology, Penn State University College of Medicine, Hershey, PA, 
      USA. Electronic address: fgilliam@hmc.psu.edu.
FAU - Ryvlin, Philippe
AU  - Ryvlin P
AD  - Department of Clinical Neurosciences, CHUV, Lausanne, Switzerland. Electronic 
      address: philipperyvlin@gmail.com.
FAU - Specchio, Luigi M
AU  - Specchio LM
AD  - Epilepsy Center, Clinic of Nervous System Diseases, University of Foggia, Riuniti 
      Hospital, Foggia, Italy. Electronic address: luigi.specchio@unifg.it.
FAU - Wang, Xuezhe
AU  - Wang X
AD  - Covance Market Access Services Inc., Gaithersburg, MD, USA. Electronic address: 
      Xuezhe.Wang@Covance.com.
FAU - Blum, David
AU  - Blum D
AD  - Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: 
      David.Blum@sunovion.com.
FAU - Moreira, Joana
AU  - Moreira J
AD  - BIAL - Portela & C feminine S.A., S. Mamede do Coronado, Portugal. Electronic address: 
      Joana.Moreira@bial.com.
FAU - Rocha, Francisco
AU  - Rocha F
AD  - BIAL - Portela & C feminine S.A., S. Mamede do Coronado, Portugal. Electronic address: 
      Francisco.rocha@bial.com.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151112
PL  - United States
TA  - Epilepsy Behav
JT  - Epilepsy & behavior : E&B
JID - 100892858
RN  - 0 (Anticonvulsants)
RN  - 0 (Dibenzazepines)
RN  - BEA68ZVB2K (eslicarbazepine acetate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anticonvulsants/therapeutic use
MH  - *Cost of Illness
MH  - Dibenzazepines/*therapeutic use
MH  - Double-Blind Method
MH  - Epilepsies, Partial/diagnosis/*drug therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Seizures/diagnosis/*drug therapy
MH  - *Severity of Illness Index
MH  - Surveys and Questionnaires
OTO - NOTNLM
OT  - All clinical trials
OT  - All epilepsy/seizures
OT  - Antiepileptic drugs
OT  - Partial seizures
OT  - Seizure severity
EDAT- 2015/11/18 06:00
MHDA- 2016/07/19 06:00
CRDT- 2015/11/18 06:00
PHST- 2015/08/07 00:00 [received]
PHST- 2015/09/14 00:00 [revised]
PHST- 2015/09/15 00:00 [accepted]
PHST- 2015/11/18 06:00 [entrez]
PHST- 2015/11/18 06:00 [pubmed]
PHST- 2016/07/19 06:00 [medline]
AID - S1525-5050(15)00533-8 [pii]
AID - 10.1016/j.yebeh.2015.09.018 [doi]
PST - ppublish
SO  - Epilepsy Behav. 2015 Dec;53:149-53. doi: 10.1016/j.yebeh.2015.09.018. Epub 2015 
      Nov 12.