Treatment of partial seizures with gabapentin: Double‐blind, placebo‐controlled, parallel‐group study*

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 doseresponse (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.

Neocortical Post-Traumatic Epileptogenesis Is Associated with Loss of GABAergic Neurons

“…On the other hand, some studies suggested that GABAergic neurons are selectively spared following some other insults (Mathern et al, 1995; Tecoma et al, 1989). Nevertheless, the fact that epilepsy may be treated using drugs that enhance GABA receptor mediated inhibition (Fueta et al, 2005; Yamauchi et al, 2006) and that seizures can be triggered with GABA receptor blockers, such as penicillin and bicuculline (Karlsson et al, 1992), suggests that altered inhibition might represent an important pathogenetic mechanism of chronic epileptogenesis.…”

Central nervous system adverse effects of new antiepileptic drugs

“…In recent years, several doubleblind studies of new AEDs have been published. [7][8][9][10][11][12][13][14] As far as we know, these studies have not been included in the previous meta-analyses in which adverse effects have been evaluated.…”

Effects of Ethyl Loflazepate on Refractory Epilepsy in Children

“…Patients were recruited from 6 Japanese hospitals and selected according to the following criteria: (1) between 3 months and 18 years old, (2) seizures refractory to at least 2 first-line antiepileptic drugs, (3) at least 4 seizures a month during the 3 months before ethyl loflazepate administration, and (4) at least 24 months of follow-up.…”