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Forschungsdatenbank PMU-SQQUID

Levetiracetam in children with refractory epilepsy: A multicenter open label study in Germany
Opp, J; Tuxhorn, I; May, T; Kluger, G; Wiemer-Kruel, A; Kurlemann, G; Gross-Selbeck, G; Rating, D; Brandl, U; Bettendorf, U; Hartel, C; Korn-Merker, E
SEIZURE-EUR J EPILEP. 2005; 14(7): 476-484.
Originalarbeiten (Zeitschrift)


Kluger Gerhard


To evaluate the efficacy and tolerability of Levetiracetam (LEV) in a large pediatric cohort with drug-resistant epilepsy from a prospective multicenter observational study.
We report the results of a multicenter observational survey of a cohort of 285 pediatric patients (mean: 9.9 years, range: 0; 6-17; 11) with refractory generalized and focal epilepsy who received Levetiracetam as an add-on open label treatment trial. The average duration of epilepsy was 6.0 years and the patients were treated with a mean of 7.0 antiepileptic drugs (AED) before LEV was introduced.
No serious persistent adverse events were reported. Reversible colitis and an apnoea syndrome in a child with phosphorylase-A-kinase-deficiency were noted. Mild to moderate side effects were reported in 128 patients (44.9%), consisting most frequently of somnolence (23.9%), general behavioral changes (15.4%), aggression (10.5%) and sleep disturbances (3.2%). In 209 patients, efficacy was analyzed over a treatment period of at least 12 weeks compared to a baseline of 2 weeks. Thirteen patients (6.2%) became seizure free, 39 (18.7%) responded with a seizure reduction of more than 50% following introduction of LEV. No response to LEV was reported in 65.1% (n=136). A decrease of initial treatment effect was seen in 37 patients (17.8%) while in 6.7% the seizure frequency doubled to the baseline (n=14). In seven patients (3.3%), the effect of LEV on seizure frequency could not be evaluated. A positive psychotropic effect was observed in 18 patients (8.6%). Mental retardation was associated with poor response and associated with more side effects and earlier discontinuation of LEV therapy.
LEV is a well-tolerated new AED that may effectively improve seizure control as an add-on drug in resistant epilepsy in childhood with good tolerability. However, neurologically handicapped children appear at increased risk for reversible neurocognitive side effects and have a poorer treatment response.

Useful keywords (using NLM MeSH Indexing)

Anticonvulsants/therapeutic use*


Child, Preschool


Drug Evaluation

Drug Therapy, Combination

Epilepsy/drug therapy*






Infant, Newborn


Piracetam/adverse effects



Piracetam/therapeutic use

Prospective Studies

Retrospective Studies

Single-Blind Method

Treatment Outcome

Find related publications in this database (Keywords)

open label add-on study
drug-resistant epilepsy