Premium
Treatment of partial seizures with gabapentin: Double‐blind, placebo‐controlled, parallel‐group study *
Author(s) -
YAMAUCHI TOSHIO,
KANEKO SUNAO,
YAGI KAZUICHI,
SASE SHINICHI
Publication year - 2006
Publication title -
psychiatry and clinical neurosciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.609
H-Index - 74
eISSN - 1440-1819
pISSN - 1323-1316
DOI - 10.1111/j.1440-1819.2006.01553.x
Subject(s) - gabapentin , placebo , tolerability , medicine , anesthesia , adverse effect , somnolence , clinical endpoint , epilepsy , anticonvulsant , population , refractory (planetary science) , randomized controlled trial , psychiatry , physics , alternative medicine , environmental health , pathology , astrobiology
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.