NCT03747705Unknown不适用
A Controlled Trial for Prevention of Loss of the Effect of Epilepsy Drugs
Tahel Ilan Ber0 个研究点目标入组 20 人开始时间: 2019年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Change in seizure frequency from baseline to the seizure count evaluation period
研究概览
简要总结
Trial for epilepsy patients non-responsive to AEDs, using medical app reminding patients to take their physician-prescribed medications
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom seizures are not controlled by their anti-seizure medication
- •Must have at least 2 seizures per month
- •History of any of the following seizure types: tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized, complex partial seizures and drop attacks (tonic/atonic)
- •At least four clinically countable seizures within 4 weeks of study entry [tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized and/or complex partial seizures and drop attacks (tonic/atonic)]
- •The subject to a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
- •History of treatment with at least two AEDs, including one trial of a combination of at least two concomitant drugs, without successful seizure control
- •Subjects with vagal nerve stimulation system must be in stable settings for a minimum of 6 months prior to enrollment
- •RNS deep brain stimulation or the ketogenic diet can be considered equivalent to a drug trial and must be on a stable ratio for a minimum of 3 months prior to enrollment
- •Completed seizure diary for four weeks (±3 days) prior to initiation of the dose titration period (visit 2). The subject will be considered a screen failure if seizure diary was not appropriately completed
- •Anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment.
排除标准
- •Neurodegenerative or deteriorated neurological disease
- •Psychosis or past psychotic event and/or anxiety disorder
- •Current or history of drug abuse/addiction
- •Abnormal creatinine
- •Any chronic ophthalmology disease
- •The subject is currently using or has used cannabis-based or synthetic cannabinoid within three months of study entry
- •Renal, hepatic [ALT/AST >2x upper limit of normal (ULN), bilirubin >2x ULN], pancreatic dysfunctions or laboratory test abnormalities, at the investigator's discretion
- •The subject is pregnant, lactating, or planning a pregnancy during the course of the study or within 3 months of study completion
- •The subject is currently enrolled in or has not yet completed a period of at least 60 days since ending another investigational device or drug trial(s)
- •Unable to comply with study visits/requirements
- •Diagnosis of Dravet Syndrome, Lennox-Gastaut syndrome, or any other congenital or childhood syndrome will be excluded completely from this trial
- •Female subjects who are pregnant will be excluded from the study. If a female subject is able to become pregnant, she will be given a serum pregnancy test before entry into the study. Female subjects will be informed not to become pregnant while on trial. Female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if they become pregnant during the study
结局指标
主要结局
Change in seizure frequency from baseline to the seizure count evaluation period
时间窗: 10 weeks
次要结局
- Changes in the Number of Anti-epileptic Drugs Prescribed(10 weeks)
- Changes in Anti-Epileptic Drugs (AEDs) in patients with less than a 50% reduction in seizures(10 weeks)
- Change in seizure frequency from baseline to the seizure count evaluation period(10 weeks)
- Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment(10 weeks)
研究者
Tahel Ilan Ber
CMO
Oberon Sciences LTD
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