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
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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
    Primary completion date:
    2012-12-12
    Observational study model:
    Other
    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:
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria: Have participated to a study that meets the following criteria: Be a study of retigabine or lacosamide as an adjunctive 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

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

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website