Rising dose study of safety and tolerance of flunarizine

Eur J Clin Pharmacol. 1995;49(1-2):91-4. doi: 10.1007/BF00192365.

Abstract

In a recent NIH-sponsored parallel-group placebo-controlled blinded study of flunarizine for the treatment of partial-onset seizures, the flunarizine serum concentration was controlled to a constant level among patients in order to reduce response variability. Flunarizine was found to exhibit modest anti-epileptic efficacy. A potential criticism of this study is that the chosen controlled concentration was too low to determine optimal efficacy. As a participating center in this study we investigated the effect of higher doses of open-label flunarizine on seizure frequency in 16 patients with refractory partial seizures. Following the completion of the blinded placebo/flunarizine phase, all patients were initiated at the flunarizine dose calculated to result in a serum concentration of 60 ng.ml-1. The dose was subsequently increased each 8-12 weeks to a maximum of 2.7 times the initial dose. On the initial maintenance flunarizine dose, seizure control was improved, with an average seizure reduction of 47% compared to pre-blinded-phase baseline. When higher doses were administered, adverse reactions were more common yet improved seizure control did not occur in most patients. These findings complement those of the concentration-controlled NIH study and suggest that appropriate flunarizine doses were utilized in that study.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Anticonvulsants / administration & dosage*
  • Anticonvulsants / adverse effects
  • Anticonvulsants / blood
  • Epilepsies, Partial / blood
  • Epilepsies, Partial / drug therapy*
  • Female
  • Flunarizine / administration & dosage*
  • Flunarizine / adverse effects
  • Flunarizine / blood
  • Humans
  • Male
  • Middle Aged

Substances

  • Anticonvulsants
  • Flunarizine