Levetiracetam for partial seizures: Results of a double-blind, randomized clinical trial

James Cereghino, V. Biton, B. Abou-Khalil, F. Dreifuss, L. J. Gauer, I. Leppik

Research output: Contribution to journalArticle

493 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
StatePublished - Jul 25 2000

Fingerprint

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

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Cereghino, J., Biton, V., Abou-Khalil, B., Dreifuss, F., Gauer, L. J., & Leppik, I. (2000). Levetiracetam for partial seizures: Results of a double-blind, randomized clinical trial. Neurology, 55(2), 236-242.

Levetiracetam for partial seizures : Results of a double-blind, randomized clinical trial. / Cereghino, James; Biton, V.; Abou-Khalil, B.; Dreifuss, F.; Gauer, L. J.; Leppik, I.

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

Research output: Contribution to journalArticle

Cereghino, J, Biton, V, Abou-Khalil, B, Dreifuss, F, Gauer, LJ & Leppik, I 2000, 'Levetiracetam for partial seizures: Results of a double-blind, randomized clinical trial', Neurology, vol. 55, no. 2, pp. 236-242.
Cereghino J, Biton V, Abou-Khalil B, Dreifuss F, Gauer LJ, Leppik I. Levetiracetam for partial seizures: Results of a double-blind, randomized clinical trial. Neurology. 2000 Jul 25;55(2):236-242.
Cereghino, James ; Biton, V. ; Abou-Khalil, B. ; Dreifuss, F. ; Gauer, L. J. ; Leppik, I. / Levetiracetam for partial seizures : Results of a double-blind, randomized clinical trial. In: Neurology. 2000 ; Vol. 55, No. 2. pp. 236-242.
@article{db3fb1d0a4854e348d0c47883cc3cc3f,
title = "Levetiracetam for partial seizures: Results of a double-blind, randomized clinical trial",
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.",
author = "James Cereghino and V. Biton and B. Abou-Khalil and F. Dreifuss and Gauer, {L. J.} and I. Leppik",
year = "2000",
month = "7",
day = "25",
language = "English (US)",
volume = "55",
pages = "236--242",
journal = "Neurology",
issn = "0028-3878",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

TY - JOUR

T1 - Levetiracetam for partial seizures

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

AU - Cereghino, James

AU - Biton, V.

AU - Abou-Khalil, B.

AU - Dreifuss, F.

AU - Gauer, L. J.

AU - Leppik, I.

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.

UR - http://www.scopus.com/inward/record.url?scp=0033854805&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033854805&partnerID=8YFLogxK

M3 - Article

C2 - 10908898

AN - SCOPUS:0033854805

VL - 55

SP - 236

EP - 242

JO - Neurology

JF - Neurology

SN - 0028-3878

IS - 2

ER -