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Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01587339
First received: April 26, 2012
Last updated: September 12, 2013
Last verified: September 2013

April 26, 2012
September 12, 2013
September 2010
March 2011   (final data collection date for primary outcome measure)
  • Responder Rate [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: No ]
    Proportion of patients who respond to treatment (50% reduction in seizure frequency from baseline)
  • Median Seizure reduction [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: No ]
    Median percent reduction in seizure frequency from baseline
  • Seizure severity [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: No ]
    Seizure severity (any definitions acceptable)
  • Time to onset of treatment effect [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: No ]
    Time to onset of treatment effect
  • Seizure free patients [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: No ]
    Proportion of patients who are seizure free (and time period over which this was measured)
  • Changes in HRQoL [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: No ]
    Changes in HRQoL
  • All drop outs [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: No ]
    Proportion of patients who drop out of the studies for any reason
  • Drop outs due to AE [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: Yes ]
    Proportion of patients who drop out of the studies (as a result of adverse events i.e. tolerability)
  • Adverse events [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: Yes ]
    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
  • Mortality [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ] [ Designated as safety issue: Yes ]
    Mortality
Same as current
Complete list of historical versions of study NCT01587339 on ClinicalTrials.gov Archive Site
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Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy
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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Observational
Time Perspective: Retrospective
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Non-Probability Sample

We included published papers on studies that had recruited drug-resistant (or refractory) partial epilepsy of all types

Epilepsy
  • Drug: retigabine/ezogabine
    oral - all doses
    Other Name: Trobalt (R); Potiga (R)
  • Drug: lacosamide
    oral - all doses
    Other Name: Vimpat
  • Drug: zonisamide
    oral - all doses
    Other Name: Zonegran
  • Drug: pregabalin
    oral - all doses
    Other Name: Lyrica
  • Drug: eslicarbazepine
    oral - all doses
    Other Name: Zebinix
Drug-resistant (or refractory) partial epilepsy of all types
Drug-resistant (or refractory) partial epilepsy of all types
Interventions:
  • Drug: retigabine/ezogabine
  • Drug: lacosamide
  • Drug: zonisamide
  • Drug: pregabalin
  • Drug: eslicarbazepine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6498
July 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01587339
115049
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP