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Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587339
First Posted: April 30, 2012
Last Update Posted: September 16, 2013
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention
Epilepsy Drug: retigabine/ezogabine Drug: lacosamide Drug: zonisamide Drug: pregabalin Drug: eslicarbazepine

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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


Enrollment: 6498
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Drug-resistant (or refractory) partial epilepsy of all types
Drug-resistant (or refractory) partial epilepsy of all types
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587339


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01587339     History of Changes
Other Study ID Numbers: 115049
First Submitted: April 26, 2012
First Posted: April 30, 2012
Last Update Posted: September 16, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pregabalin
Lacosamide
Zonisamide
Ezogabine
Eslicarbazepine acetate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antioxidants
Protective Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers