Levetiracetam in a broad population of patients with refractory epilepsy: interim results of the international SKATE trial

Objective –  To prospectively assess the safety and efficacy of levetiracetam in patients with uncontrolled focal epilepsy, in a common practice‐based setting. Patients and methods –  In this phase IV, open‐label, 16‐week community‐based study, adult patients with focal seizures initially received l...

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Published in:Acta neurologica Scandinavica 2006-06, Vol.113 (6), p.387-394
Main Authors: Genton, P., Sadzot, B., Fejerman, N., Peltola, J., Despland, P.-A., Steinhoff, B., Rektor, I., Wroe, S., Maubrey, M.-C., Vandervelden, C., Van Hammée, G., Schlit, A.-F., Van Paesschen, W.
Format: Article
Language:English
Subjects:
Adult
Anticonvulsants - administration & dosage
Anticonvulsants - adverse effects
Biological and medical sciences
clinical trial
Disorders of Excessive Somnolence - chemically induced
Dizziness - chemically induced
Dose-Response Relationship, Drug
Drug Resistance - physiology
Epilepsy - drug therapy
Epilepsy - physiopathology
Female
focal epilepsy
Headache - chemically induced
Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy
Human viral diseases
Humans
Infectious diseases
International Cooperation
levetiracetam
Male
Medical sciences
Middle Aged
Nervous system (semeiology, syndromes)
Neurology
open-label
Piracetam - administration & dosage
Piracetam - adverse effects
Piracetam - analogs & derivatives
Prospective Studies
Sensation Disorders - chemically induced
Treatment Outcome
Viral diseases
Viral diseases of the nervous system
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Summary:Objective –  To prospectively assess the safety and efficacy of levetiracetam in patients with uncontrolled focal epilepsy, in a common practice‐based setting. Patients and methods –  In this phase IV, open‐label, 16‐week community‐based study, adult patients with focal seizures initially received levetiracetam 1,000 mg/day. Throughout the study, the dose was adjusted in increments of 1,000 mg (maximum 3,000 mg/day) to achieve seizure control and maintain tolerability. The outcome parameters were the percentage reduction in partial and total seizure frequency per week from historical baseline, global evaluation scale (GES), and adverse events (AE). Results –  Seven hundred and thirty‐one patients were included in this analysis and 84.4% completed the study. The median percent reduction in all seizures was 47.8%, and 49.3% for all partial seizures. The 50% responder rate was 49%, and the seizure‐free rate was 17.2% for all partial seizures. Approximately 60% of patients showed moderate to marked improvement on the GES. The majority of AE were of mild to moderate severity; the most commonly reported being asthenia, somnolence, headache, and dizziness. Conclusion –  Levetiracetam is both efficacious and safe as an add‐on therapy in patients with refractory epilepsy treated by clinicians in their daily practice.
ISSN:0001-6314
1600-0404
DOI:10.1111/j.1600-0404.2006.00647.x