Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

NCT01587339 COMPLETED

There are a number of anti-epileptic drugs available for the treatment of partial onset seizures in patients with epilepsy. This study is a systematic review of the published literature on anti-epileptic drugs and is designed to compare the relative effectiveness and tolerability of a selection of them with retigabine. The drugs chosen for this comparison were lacosamide, pregabalin, tiagabine, zonisamide and eslicarbazepine. They were chosen because they belong to the newer generation of drugs for epilepsy (as does retigabine) and they have a similar license as well as having published data from studies that were conducted in similar patient populations with similar methods. GSK commissioned YHEC (York Health Economic Consortium) to carry out this review and analysis. YHEC identified relevant studies from international databases. These studies had compared one of the chosen anti-epileptic drugs with placebo. The results were pooled and combined in order to summarize the data for individual drugs as well to compare the results for different drugs with each other and with retigabine. Since none of the individual clinical studies compared one active drug with another, this systematic review is an indirect comparison of these drugs, using an established and recognised methodology which has well understood limitations.

Details

Lead sponsor	GlaxoSmithKline
Status	COMPLETED
Enrolment	6498
Start date	2010-09
Completion	2011-07

Conditions

• Epilepsy

Interventions

• retigabine/ezogabine
• lacosamide
• zonisamide
• pregabalin
• eslicarbazepine

Primary outcomes

• Responder Rate — Duration of studies included in the systematic review up to 28 weeks of double blind period
  Proportion of patients who respond to treatment (50% reduction in seizure frequency from baseline)
• Median Seizure reduction — Duration of studies included in the systematic review up to 28 weeks of double blind period
  Median percent reduction in seizure frequency from baseline
• Seizure severity — Duration of studies included in the systematic review up to 28 weeks of double blind period
  Seizure severity (any definitions acceptable)
• Time to onset of treatment effect — Duration of studies included in the systematic review up to 28 weeks of double blind period
  Time to onset of treatment effect
• Seizure free patients — Duration of studies included in the systematic review up to 28 weeks of double blind period
  Proportion of patients who are seizure free (and time period over which this was measured)
• Changes in HRQoL — Duration of studies included in the systematic review up to 28 weeks of double blind period
  Changes in HRQoL