NCT00616148已完成2 期
Pharmacodynamic Evaluation of YKP3089 in Epilepsy Patients With a Photo-induced Paroxysmal EEG-Response: Proof of Principle
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Determine if YKP3089 will reduce or abolish the photosensitivity response as compared to placebo.
研究概览
简要总结
The aim of this study is to evaluate the ability of a single oral dose of YKP3089 to abolish or clearly reduce the IPS-induced photo-paroxysmal EEG response in photosensitive epilepsy patients, and to measure the onset and duration of the effect. Several cohorts will be used, to sequentially investigate different doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18-60 years.
- •A diagnosis and history of epilepsy for which patients are on 0-2 concomitant antiepileptic drugs.
- •If the patient is taking two concomitant medications, the second drug must be levetiracetam, gabapentin or pregabalin.
- •A reproducible IPS-induced photo-paroxysmal response (PPR) on EEG of at least 3 points on a frequency assessment scale (See Section 6.16) in at least one eye condition and no change of more than 3 frequencies in 2 repeated measurements recorded over the 2 months prior to study entry in at least one eye condition.
- •Patients in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations.
- •A body mass index (BMI) between 18 and
- •Able and willing to provide written informed consent to participate in the study in accordance with the ICH, GCP guidelines.
排除标准
- •A history of non epileptic seizures (e.g. metabolic, structural or pseudo-seizures).
- •Women who are pregnant or lactating.
- •Women of reproductive potential who do not agree to use effective birth-control methods.
- •Patients taking medications that are known substrates of CYP2B6 and CYP2C19 including but not limited to phenytoin, Phenobarbital, omeprazole, fluvoxamine and efavirenz.
- •Any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the patient from the study.
- •An active CNS infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results.
- •Any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the patient's ability to participate in the study.
- •Patients who are suffering from clinically significant active liver disease, porphyria or with a family history of severe hepatic dysfunction indicated by abnormal liver function tests greater than 3 times the upper limit of normal (AST and ALT).
- •A history of alcoholism, drug abuse, or drug addiction (within the past 12 months).
- •Patients who would normally be contraindicated for YKP3089 administration.
- •Patients who have participated in any other trials involving an investigational product or device within 30 days of screening or longer as required by local regulations.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
YKP3089
Experimental
干预措施: YKP3089 (Drug)
结局指标
主要结局
Determine if YKP3089 will reduce or abolish the photosensitivity response as compared to placebo.
时间窗: At the completion of each cohort
次要结局
- Assessment of serum concentrations of concomitant AEDs during administration of YKP3089 as compared to the placebo day. Assessment of safety/tolerability at multiple dose levels.(At the completion of each cohort)
研究者
研究点 (4)
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