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Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01587339
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date April 26, 2012
First Posted Date April 30, 2012
Last Update Posted Date September 16, 2013
Study Start Date September 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2012)
  • 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)
  • 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
  • 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)
  • 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
  • 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)
  • Changes in HRQoL [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ]
    Changes in HRQoL
  • 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
  • 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)
  • 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
  • Mortality [ Time Frame: Duration of studies included in the systematic review up to 28 weeks of double blind period ]
    Mortality
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy
Official Title Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population We included published papers on studies that had recruited drug-resistant (or refractory) partial epilepsy of all types
Condition Epilepsy
Intervention
  • 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
Study Groups/Cohorts 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
Publications * Martyn-St James M, Glanville J, McCool R, Duffy S, Cooper J, Hugel P, Lane PW. The efficacy and safety of retigabine and other adjunctive treatments for refractory partial epilepsy: a systematic review and indirect comparison. Seizure. 2012 Nov;21(9):665-78. doi: 10.1016/j.seizure.2012.07.011. Epub 2012 Aug 14. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 26, 2012)
6498
Original Actual Enrollment Same as current
Actual Study Completion Date July 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01587339
Other Study ID Numbers 115049
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2013