Clinical trial NCT01587339: Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy
Official title: Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 6498
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included published papers on studies that had recruited drug-resistant (or refractory) partial epilepsy of all types

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Have participated to a study that meets the following criteria:
* Be a study of retigabine, eslicarbazepine, lacosamide, zonisamide, pregabalin or tiagabine as an adjuvant therapy, compared to placebo or another drug;
* Be a randomized, placebo-controlled, add-on trial, or a parallel trial or cross-over trial in which data from the first treatment period could be treated as a parallel study;
* Have recruited patients with drug-resistant partial epilepsy (i.e., simple partial, complex partial, and/or secondarily generalised tonic-clonic seizures not controlled by at least 1 or more other AEDs);
* Have a maintenance treatment period of 8 weeks or longer, with a prospective baseline of minimum 4 weeks.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Responder Rate
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
measure: Median Seizure reduction
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
measure: Seizure severity
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
measure: Time to onset of treatment effect
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
measure: Seizure free patients
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
measure: Changes in HRQoL
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
measure: All drop outs
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
measure: Drop outs due to AE
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
measure: Adverse events
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
measure: Mortality
timeFrame: Duration of studies included in the systematic review up to 28 weeks of double blind period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Martyn-St James M, Glanville J, McCool R, Duffy S, Cooper J, Hugel P, Lane PW. The efficacy and safety of retigabine and other adjunctive treatments for refractory partial epilepsy: a systematic review and indirect comparison. Seizure. 2012 Nov;21(9):665-78. doi: 10.1016/j.seizure.2012.07.011. Epub 2012 Aug 14.