Effect of levetiracetam on epilepsy-related quality of life. N132 Study Group

Epilepsia. 2000 Jul;41(7):868-74. doi: 10.1111/j.1528-1157.2000.tb00255.x.


Purpose: To evaluate the short-term effect of levetiracetam (LEV; UCB L059) as add-on therapy on health-related quality of life in the treatment of refractory partial-onset seizures.

Methods: Patients were enrolled in protocol UCB N132 if they had >/=12 partial-onset seizures with or without secondary generalization during the 12-week baseline period with a minimum of two seizures every 4 weeks. Randomization was made to placebo, LEV 1,000 mg, or LEV 3,000 mg, with sample size based on seizure frequency reduction. The 31-item Quality of Life in Epilepsy (QOLIE-31) questionnaire was completed by 246 patients at the end of baseline and at 18-week follow-up, or earlier if withdrawn.

Results: Significant differences were found among the three treatment groups for Seizure Worry (p = 0. 0003), Overall Quality of Life (p = 0.04), and Cognitive Functioning domains (p = 0.01), as well as the Total Score (p = 0.009). Responders (>/=50% partial onset seizure reduction) had significant improvements in all areas, except Medication Effect, compared with nonresponders (all p > 0.006). Clinically noticeable improvement (>/=10% change from baseline to follow-up) was perceived by LEV 3, 000 mg responders in all areas, except Emotional Well-Being, by LEV 1,000 mg responders in 5 of 9 areas, and by placebo responders in 2 of 9 areas.

Conclusions: Addition of LEV to standard medication seems to have a positive impact on health-related quality of life, particularly among responders in this short-term study. These exploratory analyses require additional studies to evaluate long-term changes in a larger population.

Publication types

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

MeSH terms

  • Adult
  • Anticonvulsants / adverse effects
  • Anticonvulsants / therapeutic use*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Epilepsies, Partial / diagnosis
  • Epilepsies, Partial / drug therapy*
  • Epilepsies, Partial / psychology
  • Female
  • Follow-Up Studies
  • Health Status Indicators*
  • Humans
  • Levetiracetam
  • Male
  • Piracetam / adverse effects
  • Piracetam / analogs & derivatives*
  • Piracetam / therapeutic use
  • Placebos
  • Quality of Life*
  • Sickness Impact Profile
  • Surveys and Questionnaires
  • Treatment Outcome


  • Anticonvulsants
  • Placebos
  • Levetiracetam
  • Piracetam