The Diagnosis and Management of Patients With Epilepsy: Nationwide, Multicenter Study of Recordings for the Diagnosis and Management of Patients With Epilepsy and Treatment With Levetiracetam in Daily Clinical Practice in Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Change in seizures' status (Change of number of seizures from baseline)
研究概览
简要总结
Epilepsy is one of the most common neurological diseases.Approximately 53 million people suffering from chronic recurrent epilepsy in 1990 and that number increased about 58 million in 2005.
The annual incidence of epilepsy varies considerably in different epidemiological studies, ranging from 11 cases per 100,000 general population to 230 cases per 100,000 people.
To date there has been discovered the ideal Antiepileptic Drugs. The drug, ie, that are safe and effective, it has good daily administration frequency, easily administered from all roads, which has high bioavailability, which is not highly bound to proteins, and not holding inductive or inhibitory effect.
详细描述
There are broad-spectrum anticonvulsant, which means that a drug can be very effective for a patient, but may or may not regulate and increase the frequency of another crisis. Thus there remains now only to choose one among a number of drugs, the most appropriate.This study intends to register within 12 months clinical practice in Greek reality as regards the elements of diagnosis and management of patients with epilepsy and those who already are, or are part of treatment with levetiracetam.
The aims of this clinical study is to record data on
- the diagnosis
- The management of epilepsy in daily clinical practice in a sample of Greek population
- The monitoring of patients entering or already undergoing treatment with levetiracetam.
- The assessment of quality of life between visits of the study by using quality of life QOLIE-31 questionnaire
- The economic evaluation of the change in treatment from original to generic levetiracetam This is a data recording study and evaluation of treatment with levetiracetam. The study will take place in 15 antiepileptic centers throughout Greece. Researchers will have to successively record all incidents of patients (30 per center) with epilepsy, which are new diagnoses or already diagnosed and are treated with levetiracetam.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Males and Females
- •Age> 6 years
- •Patients diagnosed with epilepsy or
- •Patients who are diagnosed and treated with antiepileptic treatment levetiracetam
- •Patients who consent to their participation in the study
- •Patients will comply with the requirements and procedures of the study
排除标准
- •Patients who did not consent to their participation in the study
- •Patients who will not comply to the needs and the design process
结局指标
主要结局
Change in seizures' status (Change of number of seizures from baseline)
时间窗: 12 months
Change of number of seizures from baseline
次要结局
- Change in adverse events(12 months)
- Change in treatment cost(12 months)
- Change in Quality of Life(12 months)