Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

Epilepsy Clinical Trial

Official title:

Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587339
• Other study ID #: 115049
• Status: Completed
• Phase: N/A
• First received: April 26, 2012
• Last updated: September 12, 2013
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: No Health Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6498
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

Drug:
• retigabine/ezogabine
oral - all doses
• lacosamide
oral - all doses
• zonisamide
oral - all doses
• pregabalin
oral - all doses
• eslicarbazepine
oral - all doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Seizure severity	Seizure severity (any definitions acceptable)	Duration of studies included in the systematic review up to 28 weeks of double blind period	No
Primary	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	No
Primary	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	No
Primary	Changes in HRQoL	Changes in HRQoL	Duration of studies included in the systematic review up to 28 weeks of double blind period	No
Primary	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	No
Primary	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	Yes
Primary	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	Yes
Primary	Mortality	Mortality	Duration of studies included in the systematic review up to 28 weeks of double blind period	Yes