NCT03793868已完成早期 1 期
Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Motor threshold (MT)
研究概览
简要总结
To evaluate if transcranial magnetic stimulation can be used as a biomarker in Amyotrophic Lateral sclerosis (ALS).
详细描述
To measure the effect on motor threshold (MT) by transcranial magnetic stimulation (TMS) after a single dose of perampanel at two dose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Matching placebo
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A probable laboratory supported, probable or definitive ALS diagnosis by revised El Escorial criteria.
- •Sporadic or familial ALS.
- •Ages of 18-
- •Agree to use reliable contraception
- •Randomization will occur after a baseline MT has been established; any subject in whom a MT cannot be established will be excluded.
- •Caregiver willing to report adverse behavioral events. -
排除标准
- •History of epilepsy.
- •Significant laboratory abnormality (AST or alanine aminotransferase >3x upper limit of normal, or glomerular filtration rate <60)
- •History of aggressive behavior.
- •Subject unwilling to abstain from alcohol for 2 weeks after each dosing.
- •History of drug abuse in the last 5 years
- •Other severe medical conditions, including psychiatric conditions, which would cause an increased risk in the opinion of the investigator, including but not limited to renal failure and liver failure.
- •Skull defect or other physical contraindication for TMS
- •Pacemaker or implanted defibrillator
- •Inability to take study capsule by mouth
- •Females only: Subject is pregnant [as confirmed by a positive serum human chorionic gonadotropin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow use of reliable contraception.
研究组 & 干预措施
Low dose
Experimental
Perampanel 4mg PO x1
干预措施: Perampanel (Drug)
Placebo
Placebo Comparator
Receiving placebo
干预措施: Placebo (Other)
High dose
Experimental
Perampanel 8 mg PO x1
干预措施: Perampanel (Drug)
结局指标
主要结局
Motor threshold (MT)
时间窗: at 4 hours post dose
Transcranial Magnetic stimulation motor threshold change from baseline
次要结局
未报告次要终点
研究者
Bjorn E. Oskarsson
Principal Investigator
Mayo Clinic
研究点 (1)
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