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

Publication ,  Journal Article
Cereghino, JJ; Biton, V; Abou-Khalil, B; Dreifuss, F; Gauer, LJ; Leppik, I
Published in: Neurology
July 25, 2000

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 /=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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Published In

Neurology

DOI

ISSN

0028-3878

Publication Date

July 25, 2000

Volume

55

Issue

2

Start / End Page

236 / 242

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Piracetam
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Levetiracetam
  • Humans
  • Female
  • Epilepsies, Partial
  • Electroencephalography
 

Citation

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Cereghino, J. 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. https://doi.org/10.1212/wnl.55.2.236
Cereghino, J. J., V. Biton, B. Abou-Khalil, F. Dreifuss, L. J. Gauer, and I. Leppik. “Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial.Neurology 55, no. 2 (July 25, 2000): 236–42. https://doi.org/10.1212/wnl.55.2.236.
Cereghino JJ, 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):236–42.
Cereghino, J. J., et al. “Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial.Neurology, vol. 55, no. 2, July 2000, pp. 236–42. Pubmed, doi:10.1212/wnl.55.2.236.
Cereghino JJ, 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.

Published In

Neurology

DOI

ISSN

0028-3878

Publication Date

July 25, 2000

Volume

55

Issue

2

Start / End Page

236 / 242

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Piracetam
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Levetiracetam
  • Humans
  • Female
  • Epilepsies, Partial
  • Electroencephalography