CTRI/2010/091/001332未知2 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
Novartis Health care Private Limited8 个研究点 分布在 1 个国家目标入组 57 人开始时间: 待定
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 57
- 试验地点
- 8
- 主要终点
- Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
研究概览
简要总结
Target number of patients from India is 30.Planned FPFV from India is 11th November 2010.No patients screened from India
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 65.00 Day(s)（—）
- 性别
- All
入选标准
- •Male and female outpatients age 18 to 65 years (inclusive)
- •Weight of greater than or equal to 50 kg (110 lb)
- •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
- •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
- •Have no 28day seizurefree period during the 8 weeks preceding randomization
- •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.
- •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)
- •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.
- •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. Alzheimer’s disease, Parkinson’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
- •Patients having had pre-surgical evaluations may be included.
- •Also, patients having had brain surgery for partial seizures may be included, if surgery was performed greater than or equal to 1 year before randomization
- •Are on stable doses (constant for 4 weeks prior to randomization) of non AED concomitant medication Have a history of taking his/her medication(s) as directed (determined by direct questioning of patient, caregiver and or investigator knowledge of prior compliance problems if the patient had been under the investigators care prior to the study)
- •Are reliable and willing to make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver (parent, legal guardian) who can record and report the events for them
- •Have provided written informed consent before any assessments are performed.
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.
结局指标
主要结局
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
时间窗: 28 days
次要结局
- Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks(12 weeks)
- Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.)(10 weeks)
- Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.(28 days)
研究者
研究点 (8)
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