Journal article
Levetiracetam for partial seizures : Results of a double-blind, randomized clinical trial
Neurology, Vol.55(2), pp.236-242
2000
DOI: 10.1212/WNL.55.2.236
PMID: 10908898
Abstract
Objective: To evaluate the efficacy and safety of 500 mg bid and 1500 mg bid levetiracetam as adjunctive therapy for refractory partial seizures in a double-blind, randomized, placebo-controlled, parallel-group, multicenter trial. Methods: The authors studied patients with uncontrolled partial seizures (minimum 12 per 12 weeks), regardless of whether they became secondarily generalized, for 38 weeks. A 12-week baseline was followed by random assignment to adjunctive therapy with placebo (n = 95), levetiracetam 1000 mg/day (n = 98), or levetiracetam 3000 mg/day (n = 101). Upward titration over 4 weeks was followed by 14 weeks of fixed dose treatment, and concluded with an 8-week medication withdrawal period or entering a follow-up study. Results: Of 294 patients randomized, 268 completed the study. Partial seizure frequency during the entire evaluation period (primary efficacy variable) was lower with levetiracetam compared to placebo (p ≤ 0.001 for both groups). More patients responded (defined as minimum 50% reduction in partial seizure frequency) to levetiracetam than placebo, with rates of 33.0% in the 1000 mg/day and 39.8% in the 3000 mg/day group, compared to 10.8% in the placebo group (p < 0.001). Of 199 patients receiving levetiracetam, 11 became seizure free; no patient became seizure free in the placebo group. Treatment-emergent adverse events (≥10%), mostly mild to moderate in severity, with incidences higher than placebo were asthenia, dizziness, flu syndrome, headache, infection, rhinitis, and somnolence. Conclusion: Adjunctive therapy with levetiracetam was effective and well tolerated in controlling partial seizures.
Details
- Title: Subtitle
- Levetiracetam for partial seizures : Results of a double-blind, randomized clinical trial
- Creators
- J. J Cereghino - Oregon Health & Science UniversityV Biton - Arkansas Epilepsy Program, Little Rock, United StatesB ABOU-KHALIL - Vanderbilt University Medical CenterF Dreifuss - University of Virginia Hospital (Dr. DreifussL. J Gauer - UCB Pharma, Smyrna, GA, United StatesI Leppik - Minnesota Comprehensive Epilepsy Program, Minneapolis, United StatesUnited States Levetiracetam Study Group
- Contributors
- M Granner (Contributor) - University of Iowa, Neurology
- Resource Type
- Journal article
- Publication Details
- Neurology, Vol.55(2), pp.236-242
- Publisher
- Lippincott Williams & Wilkins
- DOI
- 10.1212/WNL.55.2.236
- PMID
- 10908898
- ISSN
- 0028-3878
- eISSN
- 1526-632X
- Language
- English
- Date published
- 2000
- Academic Unit
- Neurology; Neurosurgery
- Record Identifier
- 9984302214602771
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