EpilepsyPhase 3IRNCT01227902
Study of Retigabine Immediate Release as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults With Partial-Onset Seizures
A Phase 3 study testing Retigabine IR in people with Epilepsy, run by GlaxoSmithKline at 66 sites in 12 countries.
Trial summary
The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Retigabine IR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 66 sitesin 12 countries
- Study dates
- Jul 2010to Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is 18 years of age (men or women)
- Has a confident diagnosis of epilepsy with partial-onset seizures i.e., simple or complex partial seizures with or without secondary generalization (International League Against Epilepsy (ILAE) classification; 1981) for more than 24 weeks prior to the start of Baseline phase.
- Has experienced at least 4 partial-onset seizures (i.e., simple or complex partial seizures with or without secondary generalization) during an 8-week (i.e., 56 days) prospective Baseline Phase with at least one partial seizure occurring during each 4 week (i.e., 28-day) period.
- Receiving a stable dose of one of the following AEDs: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam or valproic acid. The AED dose must be stable 4 weeks prior to start of collection of baseline seizure data (retrospective or prospective) and during the Baseline period.
- Is able and willing to maintain an accurate and complete daily written seizure calendar and functional status diary or has a caregiver who is able and willing to do so for the entire duration of the study.
- Is able to comply with dosing of study drug, background AED and all study procedures.
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- Has given written informed consent, or has a legally authorized representative who has given written informed consent, prior to the performance of any study assessments.
- A female subject is eligible to enter and participate in the study if she is either of non-childbearing potential or child-bearing potential but has a negative pregnancy test at Screening and agrees to satisfy one of the contraception methods as listed in the protocol, and is not pregnant or lactating or planning to become pregnant during the study.
- French subjects only: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Who cannot join
- Has a history of generalised epilepsy (e.g. Lennox-Gastaut, Juvenile Myoclonic etc.)
- Has had status epilepticus (other than simple partial status epilepticus) within the 24 weeks prior to Baseline Visit.
- Has participated in a previous retigabine study (subjects with documented evidence of having received placebo will be eligible).
- Is currently or has been abusing substance(s) or other medications in the 12 months prior to Baseline visit.
- Has taken an investigational drug, or used an investigational device, within the previous 30 days prior to screening or plans to take an investigational drug anytime during the study.
- Is currently following or planning to follow the ketogenic diet.
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- Has been treated with vigabatrin within the past 6 months prior to collection of baseline seizure data.
- Is planning surgery or implantation of a Vagus Nerve Stimulator (VNS) to control seizures during the study.
- Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormalities that are likely to interfere with the objectives of the study.
- Has any medical condition that, in the investigator's judgment, is considered to be clinically significant and could potentially affect subject safety or study outcome.
- Has a QTc ≥450 millisecond (msec) or greater than or equal to 480 msec for subjects with Bundle Branch Block at the time of screening.
- Has active suicidal plan/intent or has had active suicidal thoughts in the past 6 months. Has history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
- French Subjects: the French subject has participated in any study using an investigational drug during the previous 30 days or 5 half-lives (whichever is longer).
Trial locations and contacts
66 sites in 12 countries.
66 sites in 12 countries
Italy10 sites
GSK Investigational Site
Bologna, Emilia-Romagna, 40139
GSK Investigational Site
Foggia, Apulia, 71100
GSK Investigational Site
Genoa, Liguria, 16153
GSK Investigational Site
Palermo, Sicily, 90129
GSK Investigational Site
Pisa, Tuscany, 56126
GSK Investigational Site
Reggio Calabria, Calabria, 89100
GSK Investigational Site
Rome, Lazio, 00163
GSK Investigational Site
Rome, Lazio, 00185
GSK Investigational Site
Siena, Tuscany, 53100
GSK Investigational Site
Torrette Di Ancona, The Marches, 60126
Germany8 sites
GSK Investigational Site
Berlin, State of Berlin, 13509
GSK Investigational Site
Bielefeld, North Rhine-Westphalia, 33617
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53105
GSK Investigational Site
Kehl-Kork, Baden-Wurttemberg, 77694
GSK Investigational Site
Kiel, Schleswig-Holstein, 24105
GSK Investigational Site
Marburg, Hesse, 35043
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70372
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076
Russia8 sites
GSK Investigational Site
Belgorod, 308007
GSK Investigational Site
Kazan', 420064
GSK Investigational Site
Krasnodar, 350007
GSK Investigational Site
Moscow, 107150
GSK Investigational Site
Moscow, 117049
GSK Investigational Site
Saint Petersburg, 193019
GSK Investigational Site
Samara, 443095
GSK Investigational Site
Smolensk, 214 019
Ukraine8 sites
GSK Investigational Site
Dnipro, 49005
GSK Investigational Site
Donetsk, 83037
GSK Investigational Site
Kharkiv, 61068
GSK Investigational Site
Luhansk, 91045
GSK Investigational Site
Lviv, 79010
GSK Investigational Site
Odesa, 65014
GSK Investigational Site
Oleksandrivka Village, Odesa, 67513
GSK Investigational Site
Poltava
France6 sites
GSK Investigational Site
Lille, 59037
GSK Investigational Site
Limoges, 87042
GSK Investigational Site
Lyon, 69677
GSK Investigational Site
Nancy, 54035
GSK Investigational Site
Rennes, 35033
GSK Investigational Site
Strasbourg, 67098
Poland5 sites
GSK Investigational Site
Iława, 13-300
GSK Investigational Site
Katowice, 40-662
GSK Investigational Site
Krakow, 31-209 Krakow
GSK Investigational Site
Warsaw, 00-453
GSK Investigational Site
Warsaw, 02-952
Bulgaria4 sites
GSK Investigational Site
Pleven, 5800
GSK Investigational Site
Plovdiv, 4000
GSK Investigational Site
Sofia, 1113
GSK Investigational Site
Sofia, 1431
Netherlands4 sites
GSK Investigational Site
Breda, 4818 CK
GSK Investigational Site
Heemstede, 2103 SW
GSK Investigational Site
Heeze, 5591 VE
GSK Investigational Site
The Hague, 2512 VA
Spain4 sites
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Seville, 41009
GSK Investigational Site
Valencia, 46026
GSK Investigational Site
Vigo, 36204
Belgium3 sites
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000
Denmark3 sites
GSK Investigational Site
Dianalund, 4293
GSK Investigational Site
Glostrup Municipality, 2600
GSK Investigational Site
Koebenhavn Oe, 2100
Thailand3 sites
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Khon Kaen, 40002
GSK Investigational Site
Songkhla, 90110
About this study
Official title: An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults With Partial -Onset Seizures
The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures (POS) using a flexible dosing regimen.
Read the detailed description
This is an open-label, multi-centre, flexible dose study of retigabine immediate release (IR). The study will enroll male and female outpatients (≥ 18 years of age) with partial-onset seizures (POS) who are inadequately controlled on their current monotherapy Antiepileptic Drug (AED). Following a Screening Period of up to 2 weeks, subjects will enter an 8-week Baseline Phase to determine baseline seizure frequency. At the end of the Baseline Phase, subjects who meet or exceed the minimum seizure frequency of 4 partial seizures per 56 days, will enter the Treatment Period (4 weeks Titration, 16 weeks Flexible Dose Evaluation Phase). All subjects will receive retigabine IR starting at 150 mg/day and will be titrated to 600 mg/day by Week 4. From Week 5 onwards, subjects' doses will be maintained between 300 to 1200 mg/day using a flexible dosing regimen to optimise response and tolerability. The maximum duration of the study is approximately 33 weeks (inclusive of a 3 week Taper/Follow-up Phase).
- Conditions
- Epilepsy
- Being tested
- Retigabine IR
- Keywords
- Seizures, retigabine IR, GW582892, Epilepsy, Open label, flexible dose, Partial-onset seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retigabine IRDrug
Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum).
| Study group | Role | What they receive |
|---|---|---|
| Retigabine IR | Experimental | Open Label flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum). Receives: Drug: Retigabine IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline
The number of participants experiencing a >=50% reduction from Baseline (BL) in POS frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A POS has its onset in a limited area on one side of the brain. POSs may remain limited or may spread to involve both sides of the brain. For both the Baseline Phase and the TP, seizure frequency was calculated as a 28-day rate using the following formula: 28 x {[(number of countable partial seizures in Phase) + (10 x number of days with innumerable seizures in Phase) + (number of occurrences of status epilepticus in Phase)] / number of applicable days in the Phase}, where all days in the Phase are considered applicable (including days with 0 seizures), except for days on which the participant failed to complete the Seizure Diary. >= 50% reduction from BL is calculated as 100 x (28-day partial seizure rate [PSR] for the TP - 28-day PSR for the BL Phase) / 28-day PSR for the BL Phase.
Measured: From Baseline through Week 20 (Day 140)/Early Withdrawal
Secondary outcomes (16)
Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency
Participants were assessed for the percent change from Baseline in seizure frequency; changes were categorized as Any Decrease (>0 to 25%, 25 to <50%, 50 to 75%, >75 to 100%) or No Change or Any Increase (>25%, 0 to 25%). A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.
Measured: From Baseline through Week 20 (Day 140)/Early Withdrawal
Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline
The number of participants experiencing a >=25%, >=75%, and 100% reduction from Baseline in partial-onset seizure frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.
Measured: From Baseline through Week 20 (Day 140)/Early Withdrawal
Percent Change From Baseline in Partial-onset Seizure Frequency
Percent change from Baseline was calculated as the difference in the partial-onset seizure frequency (Treatment Phase minus the Baseline Phase) divided by the Baseline Phase frequency, multiplied by 100. Negative values indicate reductions from Baseline. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.
Measured: From Baseline through Week 20 (Day 140)/Early Withdrawal
Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry
Participants were asked the following question daily: "How would you rate your epilepsy-related worry over the last 24 hours?" The original possible responses were 0-10, with 0="No worry" and 10="Worst worry imaginable." However, in the summarization, "1" was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline.
Measured: Baseline through Week 20/Early Withdrawal
Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to
Participants were asked the following question daily: "How would you rate the extent to which epilepsy limited your ability to do what you needed to do over the last 24 hours?" The original possible responses were 0-10, with 0="Not at all limited" and 10="Unable to do anything I needed to." However, in the summarization, "1" was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline.
Measured: Baseline through Week 20/Early Withdrawal
Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to
Participants were asked the following question daily: "How would you rate the extent to which epilepsy limited your ability to do what you wanted to do over the last 24 hours?" The original possible responses were 0-10, with 0="Not at all limited" and 10="Unable to do anything I wanted to." However, in the summarization, "1" was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline.
Measured: Baseline through Week 20/Early Withdrawal
Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time
Participants were asked the following question daily: "Did you miss any time from work or school in the last 24 hours due to epilepsy?" Possible responses were Yes, No, and NA=Not Applicable (no planned work or school in the last 24 hours). The variable summarized is the percentage of days with no missed work or school. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A positive percent change from Baseline indicates a reduction from Baseline in missed work or school.
Measured: Baseline through Week 20/Early Withdrawal
Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal
The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.
Measured: Baseline through Week 20/Early Withdrawal
Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal
The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The physical component summary (PCS) score is a summary score representing overall physical health, which is derived from the 8 domains. As with the domains, PCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.
Measured: Baseline through Week 20/Early Withdrawal
Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal
The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The mental component summary (MCS) score is a summary score representing overall mental health, which is derived from the 8 domains. As with the domains, MCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.
Measured: Baseline through Week 20/Early Withdrawal
Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score
The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?
Measured: Baseline through Week 20/Early Withdrawal
Change From Baseline in the PGI-C Score: Epilepsy-related Worry
The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.
Measured: Baseline through Week 20/Early Withdrawal
Number of Participants With the Indicated Response for the Current Ability to do the Things You Need to do Component of the PGI-C Score
The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?
Measured: Baseline through Week 20/Early Withdrawal
Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do
The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.
Measured: Baseline through Week 20/Early Withdrawal
Number of Participants With the Indicated Response for the Current Ability to do the Things You Want to do Component of the PGI-C Score
The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse.
Measured: Baseline through Week 20/Early Withdrawal
Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do
The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.
Measured: Baseline through Week 20/Early Withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 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
- NCT01227902
- Sponsor's protocol ID
- 113905
- Acronym
- IR
- Status last verified
- Oct 2014
- First submitted
- 16 Jul 2010
- Last updated
- 17 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults With Partial -Onset Seizures
- ClinicalTrials.gov ID
- NCT01227902
- Acronym / sponsor ID
- IR / 113905
- Conditions
- Epilepsy
- Keywords
- Seizures, retigabine IR, GW582892, Epilepsy, Open label, flexible dose, Partial-onset seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Posted 11 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures (POS) using a flexible dosing regimen.
Detailed description
This is an open-label, multi-centre, flexible dose study of retigabine immediate release (IR). The study will enroll male and female outpatients (≥ 18 years of age) with partial-onset seizures (POS) who are inadequately controlled on their current monotherapy Antiepileptic Drug (AED). Following a Screening Period of up to 2 weeks, subjects will enter an 8-week Baseline Phase to determine baseline seizure frequency. At the end of the Baseline Phase, subjects who meet or exceed the minimum seizure frequency of 4 partial seizures per 56 days, will enter the Treatment Period (4 weeks Titration, 16 weeks Flexible Dose Evaluation Phase). All subjects will receive retigabine IR starting at 150 mg/day and will be titrated to 600 mg/day by Week 4. From Week 5 onwards, subjects' doses will be maintained between 300 to 1200 mg/day using a flexible dosing regimen to optimise response and tolerability. The maximum duration of the study is approximately 33 weeks (inclusive of a 3 week Taper/Follow-up Phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retigabine IR | Experimental | Drug: Retigabine IROpen Label flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is 18 years of age (men or women)
- Has a confident diagnosis of epilepsy with partial-onset seizures i.e., simple or complex partial seizures with or without secondary generalization (International League Against Epilepsy (ILAE) classification; 1981) for more than 24 weeks prior to the start of Baseline phase.
- Has experienced at least 4 partial-onset seizures (i.e., simple or complex partial seizures with or without secondary generalization) during an 8-week (i.e., 56 days) prospective Baseline Phase with at least one partial seizure occurring during each 4 week (i.e., 28-day) period.
- Receiving a stable dose of one of the following AEDs: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam or valproic acid. The AED dose must be stable 4 weeks prior to start of collection of baseline seizure data (retrospective or prospective) and during the Baseline period.
- Is able and willing to maintain an accurate and complete daily written seizure calendar and functional status diary or has a caregiver who is able and willing to do so for the entire duration of the study.
Key exclusion criteria (13 listed)
- Has a history of generalised epilepsy (e.g. Lennox-Gastaut, Juvenile Myoclonic etc.)
- Has had status epilepticus (other than simple partial status epilepticus) within the 24 weeks prior to Baseline Visit.
- Has participated in a previous retigabine study (subjects with documented evidence of having received placebo will be eligible).
- Is currently or has been abusing substance(s) or other medications in the 12 months prior to Baseline visit.
- Has taken an investigational drug, or used an investigational device, within the previous 30 days prior to screening or plans to take an investigational drug anytime during the study.
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 IRFlexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum). | Drug | Retigabine IR |
Primary outcome
Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline
Time frame: From Baseline through Week 20 (Day 140)/Early Withdrawal
The number of participants experiencing a >=50% reduction from Baseline (BL) in POS frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A POS has its onset in a limited area on one side of the brain. POSs may remain limited or may spread to involve both sides of the brain. For both the Baseline Phase and the TP, seizure frequency was calculated as a 28-day rate using the following formula: 28 x {[(number of countable partial seizures in Phase) + (10 x number of days with innumerable seizures in Phase) + (number of occurrences of status epilepticus in Phase)] / number of applicable days in the Phase}, where all days in the Phase are considered applicable (including days with 0 seizures), except for days on which the participant failed to complete the Seizure Diary. >= 50% reduction from BL is calculated as 100 x (28-day partial seizure rate [PSR] for the TP - 28-day PSR for the BL Phase) / 28-day PSR for the BL Phase.
16 secondary outcomes
Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency
Time frame: From Baseline through Week 20 (Day 140)/Early Withdrawal
Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline
Time frame: From Baseline through Week 20 (Day 140)/Early Withdrawal
Percent Change From Baseline in Partial-onset Seizure Frequency
Time frame: From Baseline through Week 20 (Day 140)/Early Withdrawal
Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry
Time frame: Baseline through Week 20/Early Withdrawal
Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to
Time frame: Baseline through Week 20/Early Withdrawal
Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to
Time frame: Baseline through Week 20/Early Withdrawal
Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time
Time frame: Baseline through Week 20/Early Withdrawal
Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal
Time frame: Baseline through Week 20/Early Withdrawal
Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal
Time frame: Baseline through Week 20/Early Withdrawal
Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal
Time frame: Baseline through Week 20/Early Withdrawal
Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score
Time frame: Baseline through Week 20/Early Withdrawal
Change From Baseline in the PGI-C Score: Epilepsy-related Worry
Time frame: Baseline through Week 20/Early Withdrawal
Number of Participants With the Indicated Response for the Current Ability to do the Things You Need to do Component of the PGI-C Score
Time frame: Baseline through Week 20/Early Withdrawal
Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do
Time frame: Baseline through Week 20/Early Withdrawal
Number of Participants With the Indicated Response for the Current Ability to do the Things You Want to do Component of the PGI-C Score
Time frame: Baseline through Week 20/Early Withdrawal
Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do
Time frame: Baseline through Week 20/Early Withdrawal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
66 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Retigabine IR in people with Epilepsy, run by GlaxoSmithKline at 66 sites in 12 countries.
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 9 inclusion and 13 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 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Italy, Germany, Russia, Ukraine, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline (time frame: From Baseline through Week 20 (Day 140)/Early Withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2014.