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Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

NCT ID: NCT01587339

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6498 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Epilepsy

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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

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

retigabine/ezogabine

Intervention Type DRUG

oral - all doses

lacosamide

Intervention Type DRUG

oral - all doses

zonisamide

Intervention Type DRUG

oral - all doses

pregabalin

Intervention Type DRUG

oral - all doses

eslicarbazepine

Intervention Type DRUG

oral - all doses

Interventions

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retigabine/ezogabine

oral - all doses

Intervention Type DRUG

lacosamide

oral - all doses

Intervention Type DRUG

zonisamide

oral - all doses

Intervention Type DRUG

pregabalin

oral - all doses

Intervention Type DRUG

eslicarbazepine

oral - all doses

Intervention Type DRUG

Other Intervention Names

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Trobalt (R); Potiga (R) Vimpat Zonegran Lyrica Zebinix

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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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.

Reference Type BACKGROUND
PMID: 22902288 (View on PubMed)

Other Identifiers

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115049

Identifier Type: -

Identifier Source: org_study_id