Double-blind, Placebo-Controlled Trial of Topiramate (600 Mg Daily) for the Treatment of Refractory Partial Epilepsy

Epilepsia. 1996 Aug;37(8):763-8. doi: 10.1111/j.1528-1157.1996.tb00649.x.

Abstract

Purpose: We wished to evaluate adjunctive therapy for partial-onset seizures with topiramate (TPM) for efficacy and safety in a double-blind, placebo-controlled, randomized, parallel-group study.

Methods: Sixty outpatients with epilepsy (47 men and 13 women, mean age 32.9 years) were studied. All had a documented history of partial-onset seizures with or without secondarily generalized seizures. After an 8-week baseline during which patients had at least one seizure per week, 30 patients each were randomized to TPM 300 mg twice daily (b.i.d.) or placebo for 12 weeks.

Results: TPM was significantly superior to placebo, as indicated by all efficacy assessments: greater median percent reduction from baseline in the average monthly seizure rate (46 vs. -12%, p = 0.004); greater number of treatment responders (patients with > or = 50% reduction in seizure rate) (47 vs. 10%, p = 0.001), and better investigator (p = 0.002) and patient (p = 0.010) global assessments of treatment. Among TPM-treated patients, the most commonly reported adverse events (AE) were headache, somnolence, fatigue, dizziness, and abnormal thinking. Most AE were mild or moderate in severity.

Conclusions: The results of the present trial indicate that TPM 600 mg/day is effective in the treatment of refractory partial-onset seizures with or without secondarily generalized seizures.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Ambulatory Care
  • Anticonvulsants / administration & dosage
  • Anticonvulsants / blood
  • Anticonvulsants / therapeutic use*
  • Dizziness / chemically induced
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Epilepsies, Partial / drug therapy*
  • Epilepsy, Generalized / drug therapy
  • Fatigue / chemically induced
  • Female
  • Fructose / administration & dosage
  • Fructose / analogs & derivatives*
  • Fructose / therapeutic use
  • Headache / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Topiramate
  • Treatment Outcome

Substances

  • Anticonvulsants
  • Placebos
  • Topiramate
  • Fructose