A Double Blind, Randomized, Cross- Over Study Examining Efficacy Of Pf-06372865 In A Photosensitivity Epilepsy Study Using Lorazepam As A Positive Control
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 7
- 试验地点
- 16
- 主要终点
- The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition
研究概览
简要总结
PF-06372865 in subjects with photosensitive epilepsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis and history of photoparoxysmal response on electroencephalogram (EEG) with or without a diagnosis of epilepsy for which subjects are taking up to 0 - 2 concomitant antiepileptic drugs.
- •Subjects currently taking antiepileptic drug(s) to be on a stable dose for 4 weeks prior to Screening Visit.
- •A minimum average standardized photosensitive range (SPR) across all screening timepoints of 4 in the most sensitive eye condition and a non-zero average in at least one other eye condition.
排除标准
- •Subjects with a history of status epilepticus.
- •Subjects who have experienced a generalized tonic-clonic convulsion in the past 6 months, at the time of the initial screening visit.
研究组 & 干预措施
PF-06372865 dose level 1
17.5 milligram (mg) single dose
干预措施: PF-06372865 (Drug)
PF-06372865 dose level 2
52.5 mg single dose
干预措施: PF-06372865 (Drug)
Placebo
Single dose
干预措施: Placebo (Drug)
Lorazepam
2mg single dose
干预措施: Lorazepam (Drug)
结局指标
主要结局
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition
时间窗: Pre-dose, 1, 2, 4 and 6 hours post-dose
The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The primary outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose.
次要结局
- Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate(17 weeks)
- Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings(17 weeks)
- The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition(Pre-dose, 1, 2, 4 and 6 hours post-dose)
- Maximum Plasma Concentration (Cmax) of PF-06372865(1, 2, 4 and 6 hours post-dose)
- Plasma Concentration of Lorazepam(1, 2, 3, 4 and 6 hours post-dose)
- The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)(Pre-dose, 1, 2, 4 and 6 hours post-dose)
- Number of Participants With Clinically Significant Laboratory Test Abnormalities(17 weeks)
- Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865(Pre-dose, 1, 2, 3, 4 and 6 hours post-dose)
- Time for Cmax (Tmax) of PF-06372865(1, 2, 4 and 6 hours post-dose)
- Number of Participants With Treatment-emergent Adverse Events (AEs)(19 weeks)