Last updated: 02/03/2020 18:20:06

Systematic Review and Meta-Analysis: Retigabine for Adjunctive Therapy in Partial Epilepsy – updated review for Canada

GSK study ID
116931
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Systematic Review and Meta-Analysis: Retigabine for Adjunctive Therapy in Partial Epilepsy – updated review for Canada
Trial description: 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 lacosamide with retigabine. Lacosamide and retigabine belong to a newer generation of drugs for epilepsy. Published data with these treatments were collected in studies with similar patient populations and methods.
In 2010, GSK commissioned YHEC (York Health Economic Consortium) to carry out a systematic review and meta-analysis. YHEC identified relevant studies from international databases. These studies had compared retigabine, lacosamide, pregabalin, tiagabine and zonisamide with placebo. The results were pooled and combined in order to summarise 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, the systematic review was an indirect comparison of these drugs, using an established and recognised methodology which has well understood limitations.
GSK Canada has now commissioned a selective update of that systematic review, limited to retigabine and lacosamide only. It will be updated to identify studies of those interventions published since the former review was completed.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Seizure free patients

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

Adverse Events

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

Drop outs due to AE

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

Responder Rate

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

Mortality

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

Changes in HRQoL

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

Median Seizure Reduction

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

All drop-outs

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

Seizure Severity

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

Time to onset of treatment effect

Timeframe: Duration of studies included in the systematic review up to 28 weeks of double blind period

Secondary outcomes:
Not applicable
Interventions:
Drug: Retigabine/ezogabine
Drug: Lacosamide
Enrollment:
0
Observational study model:
Other
Primary completion date:
2012-12-12
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Epilepsy, Partial
Product
retigabine
Collaborators
Not applicable
Study date(s)
June 2012 to December 2012
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
  • Inclusion Criteria:
  • Have participated to a study that meets the following criteria:

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2012-12-12
Actual study completion date
2012-12-12

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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