NCT01392768已完成3 期
A Double-blind, Phase III, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam as Adjunctive Therapy, in Partial Seizures Control Associated With Refractory Focal Epilepsy
Ache Laboratorios Farmaceuticos S.A.0 个研究点目标入组 126 人开始时间: 2013年1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
- 126
- 主要终点
- Partial onset seizure frequency per week.
研究概览
简要总结
The purpose of this study is to determine whether levetiracetam as adjunctive therapy is effective in the treatment of partial seizures, with or without secondary generalization, associated with refractory focal epilepsy.
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
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, aged between 04 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
- •Patient´s weight ≥ 20kg;
- •Consistent diagnosis of refractory focal epilepsy, with or without secondary generalization;
- •Patient with onset of seizures for at least 02 years preceding the screening visit;
- •Presence at least 12 partial seizures during the 03 months preceding the screening visit (04 seizures per month);
- •Only seizures that generate motor manifestation will be recorded in this study.
- •Absence of brain injury progressive or expansive, previously documented by CT scan, MRI or other imaging test applicable (in the last 05 years;
- •Patient with electroencephalogram performed up to 02 years before this visit;
- •Subject with stable regimen (minimum of 01 month) from one to three antiepileptic drugs.
- •Vagus nerve stimulation for 04 weeks prior to V1, or use of benzodiazepines for more than 07 consecutive days will be considered as concomitant epileptic drugs)
排除标准
- •Patients with:
- •Seizures of non epileptic origin;
- •Pseudoseizures;
- •Seizures occurring in clustered patterns (03 or more seizures in 30 minutes), in the 03 months preceding the screening visit (V1);
- •History of status epilepticus while taking antiepileptic drugs during the 03 months that preceding the screening visit (V1).
- •Epileptic syndromes that occurs with cognitive deficits or secondary epilepsy evolving from some brain disease;
- •History of schizophrenia or suicide attempt;
- •Patients with psychiatric ill ongoing;
- •Presence of severe mental retardation of any etiology;
- •Previous exposure to levetiracetam;
- •Women of childbearing age who had tested positive for pregnancy, or who do not use acceptable contraceptive method, or do not agree to practice reliable contraception during the study;
- •Woman in pregnancy or lactation period;
- •Diagnosis of renal or hepatic failure;
- •Patients with genetic syndromes;
- •Patient that is taking any prohibited medication (Item 9.3);
- •Participation in last one year of clinical protocols, unless it can be direct benefit to subject;
- •Relatives of sponsor´s or study site´s employee;
- •Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the subject participation;
- •Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (e.g., blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the subject or interfere with the endpoints of study.
研究组 & 干预措施
Levetiracetam
Experimental
干预措施: Levetiracetam (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Partial onset seizure frequency per week.
时间窗: From baseline to week 24
Collection of seizure count throughout the whole study
次要结局
- Proportions of response between the groups of treatment. (Responders defined as number of patients with at least 50% reduction in the number of weekly partial seizures)(From baseline to week 24)
- Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and ECG and laboratory tests results.(From baseline to week 30)
- Percentage reduction from baseline in partial seizure frequency of days a week.(From baseline to week 24)
- Proportion of response between the groups of treatment. (Responders defined as number of subjects with at least 50% reduction in the number of days per week with partial seizures)(From baseline to week 24)
- Proportion between the groups of treatment without any kind of seizures. (seizure free)(12 weeks after the titration period (period with stable regimen of the drug))
研究者
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