PIII-81Levetiracetam intravenous infusion: A randomised placebo-controlled safety study

Abstract

BACKGROUND The primary objective was to evaluate the safety, tolerability and pharmacokinetics of levetiracetam (LEV) administered intravenously at a higher dose and/or faster infusion rate than recommended. METHODS Single ascending doses of LEV in 100 mL saline administered by intravenous (IV) infusion (2, 3, 4 g over 15 minutes; 1.5, 2, 2.5 g over 5 minutes) were evaluated in 48 healthy subjects in a randomised, single-blind, placebo-controlled study. RESULTS Adverse events (AEs) reported following IV administration of LEV (up to 4g infused over 15 minutes and up to 2.5g infused over 5 minutes) were primarily related to the central nervous system (dizziness, 52.8%; somnolence, 33.3%; fatigue, 11.1%; headache, 8.3%) and were consistent with the established safety profile for the oral formulation. Safety profiles were similar for each dose level of LEV and for both IV infusion rates, with no clear relationship noted between incidence of AEs and IV dose level or infusion rate. The pharmacokinetics of LEV administered by IV infusion were comparable across all dose groups and infusion rates. CONCLUSIONS LEV administered by IV infusion at higher doses and/or faster rates than the current maximum recommendation (1.5 g in 15 minutes) was safe and well tolerated in healthy subjects, and the pharmacokinetic profile is consistent with that for LEV administered orally. Clinical Pharmacology & Therapeutics (2005) 79, P81–P81; doi: 10.1016/j.clpt.2005.12.289