title: Assessment of behavioral and emotional functioning using standardized instruments in children and adolescents with partial-onset seizures treated with adjunctive levetiracetam in a randomized, placebo-controlled trial.
abstract: A randomized, double-blind, placebo-controlled study (N01103, NCT00105040) evaluated behavioral and emotional effects of adjunctive levetiracetam (LEV) treatment in children and adolescents (4-16years old) with uncontrolled partial-onset seizures. Patients received adjunctive LEV 20-60mg/kg/day (n=64) or placebo (n=34) for 12weeks. The Achenbach Child Behavior Checklist (CBCL) and portions of the Child Health Questionnaire-Parent Form 50 (CHQ-PF50) were used to assess behavioral and emotional functioning at baseline and end of the treatment period. Worsening of the mean CBCL Aggressive Behavior score occurred for LEV but not placebo, leading to similar results for Externalizing Syndromes and Total Problems (all P<0.05 vs placebo). The change in the CBCL Activities Competence score favored LEV (P<0.05). These results are in line with the known safety profile of LEV.
authors.affiliation: UCB, SA, Brussels, Belgium. Christine.DeLaLoge@UCB.com
authors.forename: Christine
authors.initials: C
authors.lastname: de la Loge
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Hunter
authors.forename: Jimmy
authors.initials: J
authors.lastname: Schiemann
authors.forename: Haichen
authors.initials: H
authors.lastname: Yang
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000627:therapeutic use*; D001526:Behavioral Symptoms / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D057189:Checklist; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004828:Epilepsies, Partial / Q000150:complications* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D019964:Mood Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D010889:Piracetam / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D011795:Surveys and Questionnaires
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam