EpilepsyNCT01587339
Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy
An observational study of Epilepsy, run by GlaxoSmithKline.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy
- What is being tested?
- retigabine/ezogabine, lacosamide and zonisamide
- Type of treatment
- Pill or oral medicine
- How many people
- 6,498 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We included published papers on studies that had recruited drug-resistant (or refractory) partial epilepsy of all types
Who may be able to join
- 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.
Who cannot join
- N/A
About this study
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
- Being tested
- retigabine/ezogabine, lacosamide, zonisamide, pregabalin, eslicarbazepine
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retigabine/ezogabineDrug
Also called Trobalt (R); Potiga (R)
oral - all doses
lacosamideDrug
Also called Vimpat
oral - all doses
zonisamideDrug
Also called Zonegran
oral - all doses
pregabalinDrug
Also called Lyrica
oral - all doses
eslicarbazepineDrug
Also called Zebinix
oral - all doses
| Study group | Role | What they receive |
|---|---|---|
| Drug-resistant (or refractory) partial epilepsy of all types | Drug-resistant (or refractory) partial epilepsy of all types Receives: Drug: retigabine/ezogabine; Drug: lacosamide; Drug: zonisamide; Drug: pregabalin; Drug: eslicarbazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate
Proportion of patients who respond to treatment (50% reduction in seizure frequency from baseline)
Measured: 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
Measured: Duration of studies included in the systematic review up to 28 weeks of double blind period
Seizure severity
Seizure severity (any definitions acceptable)
Measured: 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
Measured: 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)
Measured: Duration of studies included in the systematic review up to 28 weeks of double blind period
Changes in HRQoL
Changes in HRQoL
Measured: 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
Measured: 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)
Measured: 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
Measured: Duration of studies included in the systematic review up to 28 weeks of double blind period
Mortality
Mortality
Measured: Duration of studies included in the systematic review up to 28 weeks of double blind period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 6,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587339
- Sponsor's protocol ID
- 115049
- Status last verified
- Sep 2013
- First submitted
- 26 Apr 2012
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22902288
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy
- ClinicalTrials.gov ID
- NCT01587339
- Acronym / sponsor ID
- 115049
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,498 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug-resistant (or refractory) partial epilepsy of all types | – | Drug: retigabine/ezogabine, Drug: lacosamide, Drug: zonisamide, Drug: pregabalin, Drug: eslicarbazepineDrug-resistant (or refractory) partial epilepsy of all types |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We included published papers on studies that had recruited drug-resistant (or refractory) partial epilepsy of all types
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retigabine/ezogabineAlso: Trobalt (R); Potiga (R)oral - all doses | Drug | Drug-resistant (or refractory) partial epilepsy of all types |
| lacosamideAlso: Vimpatoral - all doses | Drug | Drug-resistant (or refractory) partial epilepsy of all types |
| zonisamideAlso: Zonegranoral - all doses | Drug | Drug-resistant (or refractory) partial epilepsy of all types |
| pregabalinAlso: Lyricaoral - all doses | Drug | Drug-resistant (or refractory) partial epilepsy of all types |
| eslicarbazepineAlso: Zebinixoral - all doses | Drug | Drug-resistant (or refractory) partial epilepsy of all types |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
- Background: PubMed 22902288Martyn-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate (time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.