Levetiracetam for partial seizures

Results of a double-blind, randomized clinical trial

United States Levetiracetam Study Group

Research output: Contribution to journalArticle

490 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)236-242
Number of pages7
JournalNeurology
Volume55
Issue number2
DOIs
StatePublished - Jul 25 2000
Externally publishedYes

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etiracetam
Seizures
Randomized Controlled Trials
Placebos
Therapeutics
Asthenia
Headache Disorders
Dizziness
Rhinitis
Multicenter Studies

All Science Journal Classification (ASJC) codes

  • Clinical Neurology

Cite this

Levetiracetam for partial seizures : Results of a double-blind, randomized clinical trial. / United States Levetiracetam Study Group.

In: Neurology, Vol. 55, No. 2, 25.07.2000, p. 236-242.

Research output: Contribution to journalArticle

United States Levetiracetam Study Group. / Levetiracetam for partial seizures : Results of a double-blind, randomized clinical trial. In: Neurology. 2000 ; Vol. 55, No. 2. pp. 236-242.
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T1 - Levetiracetam for partial seizures

T2 - Results of a double-blind, randomized clinical trial

AU - United States Levetiracetam Study Group

AU - Cereghino, J. J.

AU - Biton, V.

AU - Abou-Khalil, B.

AU - Dreifuss, F.

AU - Gauer, L. J.

AU - Leppik, I.

AU - Abou-Khalil, B.

AU - Bashuk, R.

AU - Beydoun, A.

AU - Biton, V.

AU - Bromficld, E.

AU - Browne, T. R.

AU - Celesia, G. G.

AU - Cereghino, J.

AU - Dean, J. C.

AU - Dengler, J.

AU - Dreifuss, F. E.

AU - Ferrendelli, J. A.

AU - Granner, M.

AU - Harden, C.

AU - Harvey, J.

AU - Hier, D. B.

AU - Hoch, D.

AU - Mutton, J. T.

AU - Iyer, V. G.

AU - Jacobson, M.

AU - King, J. A.

AU - Kirby, L. C.

AU - Lebow, S. S.

AU - Leppik, I. E.

AU - Locke, G.

AU - Matsuo, F.

AU - Newsom, M.

AU - Penovich, P.

AU - Radtke, R. A.

AU - Ramani, V.

AU - Remler, M. P.

AU - Rowan, A. J.

AU - Ruggles, K.

AU - Singer, R. P.

AU - Treiman, D. M.

AU - Michael, M.

AU - Wcstbrook, E.

AU - Willmore, L. J.

AU - Wilner, Andrew

PY - 2000/7/25

Y1 - 2000/7/25

N2 - 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.

AB - 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.

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U2 - 10.1212/WNL.55.2.236

DO - 10.1212/WNL.55.2.236

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JO - Neurology

JF - Neurology

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