CTRI/2010/091/001332Other2 期
A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Assess the Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures
ovartis Health care Private Limited0 个研究点目标入组 57 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female outpatients age 18 to 65 years (inclusive)
- •2. Weight of greater than or equal to 50 kg (110 lb)
- •3. Have a diagnosis of epilepsy (more than 2 years before screening) with partial seizures
- •with or without secondarily generalized seizures according to the International League
- •Against Epilepsys Classification of Epileptic Seizures (ILAE, 1981) Appendix 5
- •The Diagnosis should have been established by clinical history and electroencephalogram
- •(EEG) that is consistent with localization related epilepsy
- •4. Must have at least 4 partial seizures (defined as simple partial seizures with motor signs,
- •complex partial seizures, complex partial seizures with secondary generalization or a
- •combination of these types) during the 4 week baseline period and the 4 weeks
- •immediately preceding the baseline period
- •5. Have no 28day seizurefree period during the 8 weeks preceding randomization
- •6. Must have a positive test result for iGluR3 antibodies in the blood at screening. The mean
- •plus three standard deviations derived from healthy donors will be chosen as cutoff value.
- •7. Must have uncontrolled partial seizures despite having been treated with at least two
- •different antiepileptic drugs within the last 2 years prior to screening (given concurrently
- •or sequentially)
- •8. Must be receiving stable treatment (see inclusion criteria 8.1 to 8.4 and 9) with 1 or a
- •maximum of 2 AEDs from the list presented below:
- •8.1 No change in medication type, dose or frequency for 8 weeks prior to
- •randomization: Carbamazepine, Eslicarbazepine, Oxcarbazepine, Phenytoin,
- •Valproate, Lacosamide, Lamotrigine, Levetiracetam, Clobazam, Topiramate,
- •Zonisamide, Gabapentin and Pregabalin. Felbamate is only allowed, if treatment
- •has been continous for greater than or equal to 2 years.
- •8.2 No change in medication type, dose or frequency for 12 weeks prior to
- •randomization Phenobarbital and Primidone
- •8.3 Vagal nerve stimulation (VNS) will be counted as 1 AED. If using a vagal nerve
- •stimulator, the device must have been implanted for at least 5 months prior to
- •randomization. Stimulator parameters may not have been changed within 8 weeks
- •prior to randomization
- •8.4 Stable benzodiazepine treatment (no change in medication type, dose, or frequency
- •for 12 weeks prior to randomization) administered for e.g. epilepsy, anxiety, or
- •sleep disorders will be counted as one AED
- •Note: The use of intermittent benzodiazepines is defined in the exclusion criteria
- •2.5, refer to Section 4.2.
- •9. Must have had either a computed tomography (CT) or magnetic resonance imaging (MRI)
- •within the 5 years prior to screening that ruled out progressive neurological changes (e.g.
- •Alzheimerâ??s disease, Parkinsonâ??s disease) in addition, no physical examination changes
- •suggestive of such lesions or diseases should have occurred since the imaging procedure
- •If a patient has not had a CT or MRI within the past 5 years, then a MRI must be
- •performed during the screening period and the results must be reviewed for compliance
- •with above criterion prior to randomization
- •10. Patients having had pre-surgical evaluations may be included. Also, patients having had
- •brain surgery for partial seizures may be included, if surger
排除标准
- •* Presence of only non-motor simple partial seizures
- •* History of psychogenic seizures
- •* Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy;
- •* Previous history of Lennox-Gastaut syndrome
- •*Pregnant or nursing (lactating) women
- •* Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization
研究者
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