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Completed

NCT Number: NCT01587339

Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retigabine/ezogabine

Drug

oral - all doses

Other names: Trobalt (R); Potiga (R)

Lacosamide

Drug

oral - all doses

Other names: Vimpat

zonisamide

Drug

oral - all doses

Other names: Zonegran

Pregabalin

Drug

oral - all doses

Other names: Lyrica

Eslicarbazepine

Drug

oral - all doses

Other names: Zebinix

Primary outcomes

  1. Responder Rate

    Time frame: 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)

  2. Median Seizure reduction

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

    Median percent reduction in seizure frequency from baseline

  3. Seizure severity

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

    Seizure severity (any definitions acceptable)

  4. Time to onset of treatment effect

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

    Time to onset of treatment effect

  5. Seizure free patients

    Time frame: 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)

  6. Changes in HRQoL

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

    Changes in HRQoL

  7. All drop outs

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

    Proportion of patients who drop out of the studies for any reason

  8. Drop outs due to AE

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

    Proportion of patients who drop out of the studies (as a result of adverse events i.e. tolerability)

  9. Adverse events

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

    Percentage of patients reporting 5 key adverse events identified by the Cochrane Epilepsy Group as common and important adverse effects of antiepileptic drugs: ataxia, dizziness, fatigue, nausea or somnolence

  10. Mortality

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

    Mortality

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 30, 2012
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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