EUCTR2009-017744-14-BG进行中（未招募）不适用
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.
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 235 人开始时间: 2010年8月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 235
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible for enrolment in the study, a subject must meet all of the following criteria:
- •1. Is greater than or equal to 18 years of age (men or women).
- •2. Has a confident diagnosis of epilepsy with partial-onset seizures i.e., simple or complex partial seizures with or without secondary generalisation (International League Against Epilepsy (ILAE) classification; 1981) for more than 24 weeks prior to the Baseline Visit.
- •3. 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.
- •NOTE: With prior authorisation from the Sponsor, a maximum of 4 weeks (i.e., 28 days) of retrospective seizure data may replace up to the first 4 weeks (i.e., first 28 days) of the prospective Baseline Phase for subjects providing reliable documentation of the following (see Section 11, Appendix 3 or protocol):
- •A complete daily seizure diary that includes the number, and type (i.e., simple or complex partial seizures with or without secondary generalisation), of seizures experienced each day for up to 28 consecutive days immediately prior to the prospective Baseline Phase.
- •Stability of prescribed dosage of specified background AED
- •Compliance with background AED
- •All subjects permitted to use retrospective seizure data must complete a minimum of 4 weeks (i.e., 28 days) of the prospective Baseline Phase. The retrospective Baseline Phase and prospective Baseline Phase must equal 56 consecutive days.
- •4. Is currently 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 Baseline Visit (retrospective or prospective) and during the Baseline period.
- •NOTE: Benzodiazepines used in any manner other than acute usage as defined in this protocol will be considered concurrent AED usage and will not be permitted (see Section 5.5.1.2 of protocol).
- •5. 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 maintain an accurate and complete daily written calendar/diary for the entire duration of the study.
- •6. Is able to comply with dosing of study drug, background AED and all study procedures.
- •7. 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.
- •8. A female subject is eligible to enter and participate in the study if she is of:
- •a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal)
- •Pre-menopausal females with a documented (medical report verification) hysterectomy and/or bilateral oophorectomy only when reproductive status has been confirmed by hormone level assessment.
- •Post-menopausal females defined as being amenorrhoeic for greater than one year with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). However, if indicated, this should be confirmed by estradiol and FSH levels consistent with menopause (according to local laboratory ranges). Women who have not been confirmed as post-menopausal should be advised to use contraception as outlined in Section 11,Appendix 4 or p
排除标准
- •A subject meeting any of the following criteria must not be enrolled in the study:
- •1. Has a history of generalised epilepsy (e.g. Lennox-Gastaut, Juvenile Myoclonic etc.)
- •2. Has had status epilepticus (other than simple partial status epilepticus) within the 24 weeks prior to Baseline Visit.
- •3. Has participated in a previous retigabine study (subjects with documented evidence of having received placebo will be eligible).
- •4. Is currently or has been abusing substance(s) or other medications in the 12 months prior to Baseline visit.
- •5. 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.
- •6. Is currently following or planning to follow the ketogenic diet.
- •7. Has been treated with vigabatrin within the past 6 months prior to Baseline; if a subject has been previously treated with vigabatrin, a visual perimetry test after discontinuation of vigabatrin must show no visual field constriction that has been seen in some subjects taking vigabatrin.
- •8. Is planning surgery or implantation of Vagus Nerve Stimulator (VNS) to control seizures during the study. NOTE: Subjects with surgically implanted Vagus Nerve Stimulator (VNS) which is not functioning or has been switched off for at least 4 weeks prior to the Baseline Visit and remains non-functioning/off for the duration of the study will be eligible for the study.
- •9. 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.
- •10. 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, including but not limited to: clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs.
- •11. Has a QTc greater than or equal to 450 millisecond (msec) or greater than or eqal to 480msec for subjects with Bundle Branch Block at the time of screening as calculated below.
- •Note: If the initial ECG at screening indicates a QTc interval outside these limits, two further ECGs should be performed and the average QTc value of these triplicate ECGs calculated. If the average value exceeds the stated limits, the subject is not eligible.
- •12. 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.
- •13. 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).
研究者
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The purpose of this study is to test the safety of retigabine, the study drug, and how well it works at different doses when taken with other antiepileptic drugs (AEDs). We want to find out what effects, good or bad, it has on people with epileptic seizures.This study will look at how well retigabine works when added to certain other individual antiepileptic medications. The study medication will be increased at a slower rate and at different doses than used in previous studies.Epilepsy - partial-onset seizures with or without secondary generalisationMedDRA version: 14.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-017744-14-PLGlaxoSmithKline Research and Development Ltd205
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The purpose of this study is to test the safety of retigabine, the study drug, and how well it works at different doses when taken with other antiepileptic drugs (AEDs). We want to find out what effects, good or bad, it has on people with epileptic seizures.This study will look at how well retigabine works when added to certain other individual antiepileptic medications. The study medication will be increased at a slower rate and at different doses than used in previous studies.EUCTR2009-017744-14-NLGlaxoSmithKline Research and Development Ltd205
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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.EUCTR2009-017744-14-BEGlaxoSmithKline Research and Development Ltd235