title: Severity and burden of partial-onset seizures in a phase III trial of eslicarbazepine acetate.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Medical Research, Health Outcomes, Houston, TX, USA. Electronic address: joyce.cramer@gmail.com.
authors.forename: Joyce A
authors.initials: JA
authors.lastname: Cramer
authors.affiliation: Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: Fulton.Velez@sunovion.com.
authors.forename: Fulton F
authors.initials: FF
authors.lastname: Velez
authors.affiliation: Covance Market Access Services Inc., Gaithersburg, MD, USA. Electronic address: Kathryn.Anastassopoulos@Covance.com.
authors.forename: Kathryn P
authors.initials: KP
authors.lastname: Anastassopoulos
authors.affiliation: Covance Market Access Services Inc., Gaithersburg, MD, USA. Electronic address: Christopher.Bond@Covance.com.
authors.forename: T Christopher
authors.initials: TC
authors.lastname: Bond
authors.affiliation: Department of Neurology, Penn State University College of Medicine, Hershey, PA, USA. Electronic address: fgilliam@hmc.psu.edu.
authors.forename: Frank G
authors.initials: FG
authors.lastname: Gilliam
authors.affiliation: Department of Clinical Neurosciences, CHUV, Lausanne, Switzerland. Electronic address: philipperyvlin@gmail.com.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ryvlin
authors.affiliation: Epilepsy Center, Clinic of Nervous System Diseases, University of Foggia, Riuniti Hospital, Foggia, Italy. Electronic address: luigi.specchio@unifg.it.
authors.forename: Luigi M
authors.initials: LM
authors.lastname: Specchio
authors.affiliation: Covance Market Access Services Inc., Gaithersburg, MD, USA. Electronic address: Xuezhe.Wang@Covance.com.
authors.forename: Xuezhe
authors.initials: X
authors.lastname: Wang
authors.affiliation: Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: David.Blum@sunovion.com.
authors.forename: David
authors.initials: D
authors.lastname: Blum
authors.affiliation: BIAL - Portela & Cª S.A., S. Mamede do Coronado, Portugal. Electronic address: Joana.Moreira@bial.com.
authors.forename: Joana
authors.initials: J
authors.lastname: Moreira
authors.affiliation: BIAL - Portela & Cª S.A., S. Mamede do Coronado, Portugal. Electronic address: Francisco.rocha@bial.com.
authors.forename: Francisco
authors.initials: F
authors.lastname: Rocha
mesh_terms: D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use; D017281:Cost of Illness; D003984:Dibenzazepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004828:Epilepsies, Partial / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012640:Seizures / Q000175:diagnosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
chemical_list: D000927:Anticonvulsants; D003984:Dibenzazepines; C416835:eslicarbazepine acetate
keywords: All clinical trials; All epilepsy/seizures; Antiepileptic drugs; Partial seizures; Seizure severity