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Placebo-controlled study of the efficacy and safety of lamotrigine in patients with partial seizures. U.S. Lamotrigine Protocol 0.5 Clinical Trial Group.

Publication ,  Journal Article
Matsuo, F; Bergen, D; Faught, E; Messenheimer, JA; Dren, AT; Rudd, GD; Lineberry, CG
Published in: Neurology
November 1993

We evaluated the efficacy and safety of lamotrigine (300 and 500 mg/day) as add-on therapy in a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of 216 patients with refractory partial seizures. During 6 months of treatment, median seizure frequency decreased by 8% with placebo, 20% with 300 mg lamotrigine, and 36% with 500 mg lamotrigine. Seizure frequency decreased by > or = 50% in one-third of the 500-mg group and one-fifth of the 300-mg group. Reductions in seizure frequency and seizure days were statistically significant, compared with placebo, for the 500-mg group but not the 300-mg group. Most adverse events were minor and resolved over time. Nine percent of patients on lamotrigine withdrew because of adverse experiences. Lamotrigine plasma concentrations appeared to be a linear function of dose, and the drug did not affect plasma concentrations of concomitant antiepileptic drugs. Lamotrigine was safe, effective, and well tolerated as add-on therapy for refractory partial seizures.

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Published In

Neurology

DOI

ISSN

0028-3878

Publication Date

November 1993

Volume

43

Issue

11

Start / End Page

2284 / 2291

Location

United States

Related Subject Headings

  • Triazines
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Lamotrigine
  • Humans
  • Female
  • Epilepsies, Partial
  • Double-Blind Method
  • Anticonvulsants
 

Citation

APA
Chicago
ICMJE
MLA
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Matsuo, F., Bergen, D., Faught, E., Messenheimer, J. A., Dren, A. T., Rudd, G. D., & Lineberry, C. G. (1993). Placebo-controlled study of the efficacy and safety of lamotrigine in patients with partial seizures. U.S. Lamotrigine Protocol 0.5 Clinical Trial Group. Neurology, 43(11), 2284–2291. https://doi.org/10.1212/wnl.43.11.2284
Matsuo, F., D. Bergen, E. Faught, J. A. Messenheimer, A. T. Dren, G. D. Rudd, and C. G. Lineberry. “Placebo-controlled study of the efficacy and safety of lamotrigine in patients with partial seizures. U.S. Lamotrigine Protocol 0.5 Clinical Trial Group.Neurology 43, no. 11 (November 1993): 2284–91. https://doi.org/10.1212/wnl.43.11.2284.
Matsuo F, Bergen D, Faught E, Messenheimer JA, Dren AT, Rudd GD, et al. Placebo-controlled study of the efficacy and safety of lamotrigine in patients with partial seizures. U.S. Lamotrigine Protocol 0.5 Clinical Trial Group. Neurology. 1993 Nov;43(11):2284–91.
Matsuo, F., et al. “Placebo-controlled study of the efficacy and safety of lamotrigine in patients with partial seizures. U.S. Lamotrigine Protocol 0.5 Clinical Trial Group.Neurology, vol. 43, no. 11, Nov. 1993, pp. 2284–91. Pubmed, doi:10.1212/wnl.43.11.2284.
Matsuo F, Bergen D, Faught E, Messenheimer JA, Dren AT, Rudd GD, Lineberry CG. Placebo-controlled study of the efficacy and safety of lamotrigine in patients with partial seizures. U.S. Lamotrigine Protocol 0.5 Clinical Trial Group. Neurology. 1993 Nov;43(11):2284–2291.

Published In

Neurology

DOI

ISSN

0028-3878

Publication Date

November 1993

Volume

43

Issue

11

Start / End Page

2284 / 2291

Location

United States

Related Subject Headings

  • Triazines
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Lamotrigine
  • Humans
  • Female
  • Epilepsies, Partial
  • Double-Blind Method
  • Anticonvulsants