NCT03474770进行中（未招募）1 期
Evaluation of Safety and Efficacy of BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Effect of BIS-001ER on Seizure Count
研究概览
简要总结
The purpose of this study is to examine safety signals and demonstrate seizure reduction in adults with FIAS treated with BIS-001ER as an add-on therapy in an in-patient and out-patient study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Speak English with sufficient proficiency to read and comprehend the Informed Consent document, and to communicate with study staff.
- •Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study.
- •Have signed the Informed Consent before any study-specific procedures are performed.
- •Be males or females between 18 - 65 years of age.
- •Have a diagnosis of FIAS type epilepsy with or without additional focal aware or non-aware seizures with generalization.
- •Have a current minimum average of 5 countable seizures / week to enroll in study.
- •Have at least 5 focal impaired awareness seizures during the 96-hour baseline VEM period.
- •Be receiving stable doses (for at least 4 weeks) of one to four currently marketed anti-epileptic drugs (AEDs), with or without vagus nerve stimulation (in which case the patient should be on the same stimulation parameters for at least 4 weeks).
- •Have a negative urinary pregnancy test upon admission to the site on Day
- •Be in good general health in the judgment of the Principal Investigator based upon medical history, physical examination, standard 12-lead ECG, and clinical laboratory evaluations obtained within the two weeks prior to enrollment.
- •Be able to comply with all study-specified procedures.
- •Weight between 40 and 120 kg.
排除标准
- •Has taken Huperzine A within the past year.
- •Is planning to become pregnant or impregnate spouse, not using an acceptable method of birth control (defined as use of double-barrier birth control methods, use of oral contraceptives, or surgical sterilization), pregnant or nursing.
- •Have non-epileptic events that could be confused by the patient and/or study staff as epileptic seizures.
- •Has seizures that are difficult to count; for example, seizure clusters defined as multiple seizures with at least one seizure within 30 minutes of the previous seizure.
- •Have less than the 5 minimum accepted seizures required during baseline evaluation period screen.
- •Have a history of only seizure clusters, for example, seizure clusters defined as multiple seizures with at least one seizure within 30 minutes of the previous seizure.
- •Has attempted suicide within the past 2 years.
- •Has a history of status epilepticus in the 6 months previous to enrollment.
- •Has a pre-existing medical condition (including an existing progressive or degenerative neurological disorder including brain tumor, active encephalitis, active meningitis or abscess) or takes medications that, in the Principal Investigator's opinion, could interfere with the participant's suitability for participation in the study.
- •Has a history or evidence of significant psychiatric disturbance or illness, including alcohol or drug abuse within the past 2 years, or symptoms of psychosis (hallucinations, delusions) in the last 5 years.
- •Has had any clinical laboratory abnormalities within the past two months, prior to screening, considered of clinical significance by the Principal Investigator.
- •Is on concomitant therapy with non-AEDs that are cholinergic.
- •Has participated in any clinical investigational drug or device study within four weeks prior to study entry.
- •Inability to complete seizure diary.
- •Is currently taking or has taken Epigallocatechin gallate (EGCG) within the past 14 days, or consume foods or drinks containing EGCG; including green, white, oolong teas and certain black teas, or food containing >100grams of carob powder within the past 14 days.
研究组 & 干预措施
BIS-001ER
Experimental
Dose administration for each participant will begin at 0.25mg b.i.d. escalating sequentially every 4 days to a maximum tolerated dose or target dose of 1.75mg b.i.d. Upon reaching the target dose or maximum tolerated dose, participants will maintain that dose for the balance of the 1 month out-patient titration period, after which they will begin a 96-hour in-patient video EEG monitoring treatment period.
干预措施: BIS-001ER (Drug)
结局指标
主要结局
Effect of BIS-001ER on Seizure Count
时间窗: 6 Weeks
Reduction in average daily seizure count between baseline (pre-treatment) and evaluation (on treatment) video EEG monitoring periods.
次要结局
- Percent of Treatment Responders(6 Weeks)
- Effect of BIS-001ER on Percent Reduction in Daily Seizure Count(6 Weeks)
- Need for Rescue Medication(6 Weeks)
- Effect of BIS-001ER on Seizure Count vs Titration Period (Diary)(6 Weeks)
- Effect of BIS-001ER on Seizure Count During Extension Phase(12 Months)
- Complete Seizure Protection(6 Weeks)
研究者
研究点 (2)
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