Last updated: 11/07/2018 07:01:25
Study of Retigabine Immediate Release as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults with Partial-Onset SeizuresIR
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with a >=50% reduction in partial-onset seizure (POS) frequency from Baseline
Timeframe: From Baseline through Week 20 (Day 140)/Early Withdrawal
Secondary outcomes:
Number of participants with the indicated reduction or increase from Baseline in partial-onset seizure frequency
Timeframe: 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
Timeframe: From Baseline through Week 20 (Day 140)/Early Withdrawal
Percent change from Baseline in partial-onset seizure frequency
Timeframe: From Baseline through Week 20 (Day 140)/Early Withdrawal
Functional Status Diary (FSD): Percent change from Baseline in epilepsy-related worry
Timeframe: 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
Timeframe: 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
Timeframe: Baseline through Week 20/Early Withdrawal
Percent change from Baseline in functional status: percentage of days with no missed work or school time
Timeframe: 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
Timeframe: Baseline through Week 20/Early Withdrawal
Change from Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal
Timeframe: Baseline through Week 20/Early Withdrawal
Change from Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal
Timeframe: 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
Timeframe: Baseline through Week 20/Early Withdrawal
Change from Baseline in the PGI-C Score: Epilepsy-related worry
Timeframe: 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
Timeframe: Baseline through Week 20/Early Withdrawal
Change from Baseline in the PGI-C Score: Current ability to do the things you need to do
Timeframe: 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
Timeframe: Baseline through Week 20/Early Withdrawal
Change from Baseline in the PGI-C Score: Current ability to do the things you want to do
Timeframe: Baseline through Week 20/Early Withdrawal
Interventions:
Enrollment:
203
Primary completion date:
2012-04-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Holger Lerche, Jerzy Daniluk, Narinder Lotay, Sarah DeRossett, Suzanne Edwards, Christian Brandt. Efficacy and safety of ezogabine/retigabine as adjunctive therapy to specified single antiepileptic medications in an open-label study of adults with partial-onset seizures.Seizure.2015;30:93-100
Medical condition
Epilepsy
Product
retigabine
Collaborators
Not applicable
Study date(s)
July 2010 to December 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
- 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.
Exclusion criteria:
- 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.
- 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 location(s)
Location
GSK Investigational Site
Oleksandrivka village, Odesa, Ukraine, 67513
Status
Study Complete
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33617
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70372
Status
Study Complete
Location
GSK Investigational Site
Torrette di Ancona, Marche, Italy, 60126
Status
Study Complete
Location
GSK Investigational Site
Kehl-Kork, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Reggio Calabria, Calabria, Italy, 89100
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53105
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2012-04-12
Actual study completion date
2012-04-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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