Findings from Pregabalin Study May Lead to New Add-On Treatment For Partial Onset Seizures
Today, at the 58th annual AES conference in New Orleans, Jacqueline French, M.D.,Professor of Neurology at the Hospital of the University of Pennsylvania and co-director of the epilepsy center, presented the findings from a multicenter, randomized, controlled clinical trial comparing the efficacy, tolerability, and antiepileptic (AE) profiles exhibited by pregabalin. “We are optimistic about our findings in which we found pregabalin to be an effective and well-tolerated add-on treatment for patients with partial seizures,” said French.
A total of 794 patients were enrolled in two 12-week, placebo-controlled, double-blind, randomized trials in which pregabalin was used as an add-on therapy administered in both fixed and flexible dose schedules. In the fixed-dose group, patients were randomized to 1 of 3 effective dosages of pregabalin: 150, 300, or 600 mg/day or placebo. In the flexible-dose group, patients received: 150-600 mg/day which was adjusted at regular intervals depending on treatment efficacy/tolerance; or placebo.
French et al. found all pregabalin treatment to be superior to the placebo in treating partial onset seizures. Patients receiving 600 mg/day of pregabalin in both studies with a fixed-dose schedule experienced significant reductions in seizure frequency (fixed dose: 54% and 49% vs. flexible dose: 35%) versus the placebo and significant increases in responder rates versus the placebo. In addition, the AE profiles were similar for both studies with the most common AEs being: dizziness, sleepiness, ataxia, asthenia, and weight gain. Overall, pregabalin was well tolerated by all treatment groups, however, greater tolerability was exhibited by patients on the flexible-dose regimen as shown by the discontinuation rates due to AEs (fixed dose:23.6% and 32.8% vs. flexible dose:12.2%).
Currently, pregabalin is not approved by the FDA as an add-on treatment for partial epilepsy. However, French is hopeful that the data from her study will help to further the FDA approval process, which could lead to the first drug to be approved for the treatment of epilepsy since the year 2000.
The abstract of this study is published in Epilepsia, 2004,45;Supplement 7: p.74-75.