Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

NCT01587339 | Completed

• 1 other identifier: 115049
• Study Type: observational
• Target: 6,498
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (10)

• Responder Rate

  Proportion of patients who respond to treatment (50% reduction in seizure frequency from baseline)

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

• Median Seizure reduction

  Median percent reduction in seizure frequency from baseline

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

• Seizure severity

  Seizure severity (any definitions acceptable)

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

• Time to onset of treatment effect

  Time to onset of treatment effect

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

• Seizure free patients

  Proportion of patients who are seizure free (and time period over which this was measured)

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

• Changes in HRQoL

  Changes in HRQoL

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

• All drop outs

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

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

• Drop outs due to AE

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

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

• Adverse events

  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

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

• Mortality

  Mortality

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

Study Arms (1)

Drug-resistant (or refractory) partial epilepsy of all types

Drug-resistant (or refractory) partial epilepsy of all types

Drug: retigabine/ezogabine; Drug: lacosamide; Drug: zonisamide; Drug: pregabalin; Drug: eslicarbazepine

Interventions

retigabine/ezogabine DRUG

oral - all doses

Also known as: Trobalt (R); Potiga (R)

Drug-resistant (or refractory) partial epilepsy of all types

lacosamide DRUG

oral - all doses

Also known as: Vimpat

Drug-resistant (or refractory) partial epilepsy of all types

zonisamide DRUG

oral - all doses

Also known as: Zonegran

Drug-resistant (or refractory) partial epilepsy of all types

pregabalin DRUG

oral - all doses

Also known as: Lyrica

Drug-resistant (or refractory) partial epilepsy of all types

eslicarbazepine DRUG

oral - all doses

Also known as: Zebinix

Drug-resistant (or refractory) partial epilepsy of all types

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 22902288 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

ezogabine; Lacosamide; Zonisamide; Pregabalin; eslicarbazepine; eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Sulfonamides; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 16, 2013

Record last verified: 2013-09