Last updated: 11/03/2018 17:31:53

Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

GSK study ID
115049
See study documents
Clinicaltrials.gov ID
NCT01587339
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: Retigabine for Adjunctive Therapy in Partial Epilepsy
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 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Responder Rate

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

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

Seizure free patients

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

All drop outs

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

Adverse events

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

Secondary outcomes:
Not applicable
Interventions:
  • Drug: retigabine/ezogabine
  • Drug: lacosamide
  • Drug: zonisamide
  • Drug: pregabalin
  • Drug: eslicarbazepine
    • Enrollment:
    6498
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Martyn-St James, M; Glanville, J; Worthy, J; Duffy, S; Cooper, J; Hugel, P; Lane, P. The efficacy and safety of retigabine and other adjunctive treatments for refractory partial epilepsy: a systematic review and indirect comparison. [Seizure]. 2012;
    Martyn-St James, M; Glanville, J; Worthy, J; Duffy, S; Cooper, J; Hugel, P; Lane, P. The efficacy and safety of retigabine and other adjunctive treatments for refractory partial epilepsy: a systematic review and indirect comparison. Seizure. 2012;21(9):665-678.
    Medical condition
    Epilepsy
    Product
    retigabine
    Collaborators
    Not applicable
    Study date(s)
    September 2010 to March 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • 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;
    • N/A
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    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
    Not applicable
    Actual study completion date
    2011-01-03

    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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