NCT01749046已完成3 期
Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose of Remegal as Adjunctive Therapy in Patients With Partial Seizures
Valexfarm8 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 8
- 主要终点
- Seizure Frequency Reduction
研究概览
简要总结
The purpose of this study is to determine weather Remegal in fixed dosage 1500 mg/daily is effictive and safe in patients with epilepsy with partial seizures
详细描述
Phase III
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Man or woman, aged from 18 to 65
- •Diagnosis of epilepsy with simple and/or complex partial seizures both with or without secondary generalization based on the ILAE classification
- •Results of at least one prior electroencephalogram (EEG) and magnetic resonance imaging (MRI)/computerized tomography scan no more than 5 years should confirm the diagnostic of partial seizures
- •If seizures are simple partial ones, only patients with motor signs must be enrolled
- •The onset date of partial seizures according to patient's report must be at least 2 years
- •The patient must report an average of at least 8 partial seizures per 56 days prior to the baseline visit
- •The patient must not have seizure-free period longer than 21 days during the 8 weeks prior to the baseline visit (i.e between V1 and V2)
- •Patients must have been treated with at least 2 different AEDs within the last 2 years prior to the screening visit
- •The patient is capable and would like to respect all protocol requirements, include to be available for the doctor's calls and doctor's appointments at any time, follow through all protocol procedures
- •The patient agrees to self - report each seizure he has experienced between 2 visits, accurately and thoroughly, in a diary he'll be provided with
排除标准
- •Patients suffering from non-epileptic seizures
- •Patients having seizures that can't be counted due to clustering.
- •History of primary generalized seizures
- •History of status epilepticus within 12 months prior to the screening visit
- •The patient has received not permitted concomitant medications
- •The patient has a progressive structural lesion in the CNS, or a progressive encephalopathy
- •The patient is pregnant (or planning to become pregnant during the study) or is a lactating woman
- •The patient has used Remegal previously or participated in a clinical study within 24 weeks prior to the screening visit
- •The patient has experienced of any somatic disorders or psychiatric diseases and conditions which, in the opinion of the investigator, lead to health worsening or influence on the patient ability to participate in the actual clinical study
- •Vulnerable patients and individuals of majority age who are subject to legal protection or unable to express their consent
- •The patient has a history of chronic alcohol consumption or drug abuse within 2 years prior to the screening visit
- •The patient has a known history of a severe anaphylactic reaction or severe changes in blood tests
- •ALT, AST, alkaline phosphatise, total bilirubin or serum creatinine level ≥ 2 times the upper limit of normal ranges
- •Clinically important abnormalities on physical examination, vital signs, ECG or laboratory test results per-formed/obtained at the screening visit that may interfere with patient's safety, compliance, or study evaluations, ac-cording to the Investigator's opinion
- •The patient has a clinically significant disease, surgical condition or recent chronic consumption of non-AED medications (within 4 weeks prior to the screening visit) that might be reasonably expected to interfere with drug absorption, distribution, metabolism, excretion
- •QTc interval on the ECG performed at the screening visit above 500 ms
- •Diseases or concomitant medications that may prolong QTc interval
研究组 & 干预措施
Remegal
Experimental
Remegal 1500 mg
干预措施: Remegal (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Remegal (Drug)
结局指标
主要结局
Seizure Frequency Reduction
时间窗: 12 weeks
The assessment of efficacy will be based on the reduction of total partial seizure frequency reported in the patient's diary during the Treatment phase.
次要结局
- Number of Seizure's-Free Days(12 weeks)
- CGI(12 weeks)
- PGI(12 weeks)
- QOLIE(14 weeks)
研究者
研究点 (8)
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