Nebenwirkungen · Levetiracetam Actavis Group
Levetiracetam Actavis Group 100 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 12
HOS-125213 · Präparat HOS-096021
A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures. It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population. Results related to behavioral and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL – Achenbach Child Behaviour Checklist). However subjects, who took levetiracetam in the long-term open label
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