This was a multicenter study of Japan Gabapentin Study Group no. 8J with financial research support by the sponsor, Pfizer Japan.
Treatment of partial seizures with gabapentin: Double-blind, placebo-controlled, parallel-group study*
Version of Record online: 17 JUL 2006
Psychiatry and Clinical Neurosciences
Volume 60, Issue 4, pages 507–515, August 2006
How to Cite
YAMAUCHI, T., KANEKO, S., YAGI, K. and SASE, S. (2006), Treatment of partial seizures with gabapentin: Double-blind, placebo-controlled, parallel-group study. Psychiatry and Clinical Neurosciences, 60: 507–515. doi: 10.1111/j.1440-1819.2006.01553.x
- Issue online: 17 JUL 2006
- Version of Record online: 17 JUL 2006
- Received 16 February 2006; revised 10 April 2006; accepted 23 April 2006.
- adjunctive therapy;
- antiepileptic drug;
- partial seizures;
- refractory epilepsy
Abstract This double-blind study was conducted to evaluate the efficacy and safety of gabapentin 1200 mg/day and 1800 mg/day (t.i.d.) compared to placebo as an adjunctive therapy in patients with refractory epilepsy. Patients were included when they had partial seizures at least eight times during a 12-week baseline period despite treatment with one to two antiepileptic drugs. After baseline, eligible patients were randomized to gabapentin 1200 mg/day, 1800 mg/day, or placebo for 12-week treatment. The primary end-point, response ratio, was derived from seizure frequencies during treatment and baseline period based upon the seizure daily record by a patient. Of the 209 randomized patients, 86 received gabapentin 1200 mg/day, 41 received gabapentin 1800 mg/day, and 82 received placebo. A statistically significant difference was found between each of the two gabapentin groups and placebo for the primary efficacy end-point, response ratio (P < 0.005) with definite dose–response (P < 0.001). More gabapentin patients reported moderate to marked improvement in seizure frequency and intensity/duration of each seizure than placebo patients. Treatment-related adverse events were reported by approximately 65% of patients receiving gabapentin compared to approximately 46% of patients receiving placebo; somnolence and dizziness were the most common events. Gabapentin 1200 mg/day and 1800 mg/day significantly reduced the frequency of refractory seizures compared to placebo. Favorable tolerability of gabapentin was confirmed also in a Japanese population, consistent with previous global studies.