An observational study to describe the clinical impact (seizure freedom for 12 months) of clobazm (Frisium®) as an adjunct therapy in patients who are not adequately stabilized with their anticonvulsant monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 770
- 试验地点
- 31
- 主要终点
- To describe the clinical impact (seizure freedom for 12 months) of Clobazam (Frisium®) as an adjunct therapy in patients who are not adequately stabilized with their anticonvulsant monotherapy.
研究概览
简要总结
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This study is designed to assess the clinical impact of Frisium as an adjunct therapy for a period of 12 months in patients with seizures who are not adequately controlled with anticonvulsant monotherapy in the real world clinical practice in India.
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It will also help to assess the effect of Frisium as an adjuvant therapy to improve the quality of life of subject and keeping them seizure free for a period of 12 months in subjects who are not adequately stabilized with their anticonvulsant monotherapy
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In addition to this we will get the general safety of Frisium in terms of occurrence of overall adverse events.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient more than equal to 3 years of age
- •Investigator decides to prescribing Frisium as an adjunctive therapy in patients with epilepsy who are not adequately stabilized
- •Signed Informed Consent obtained from the patients or legally acceptable representative prior to any study related procedure Note-Frisium would be prescribed by the Investigator based on his/her clinical judgement.This study will not influence the Investigators decision to either prescribe or not to prescribe Frisium.If the patient is prescribed Frisium and if he/she satisfies all the inclusion and exclusion criteria, he/she may be recruited in this study.
排除标准
- •Patient with a known hypersensitivity to clobazam or any of the excipients of Frisium
- •Patient with any history of drug or alcohol dependence
- •Patient with known case of myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome or severe impairment of liver/ renal function
- •Patient with recognized epilepsy syndrome
- •Patient and/or caretaker will not be able to complete the patients diary
- •Patient participating in any clinical trial or was part of a clinical trial in the last 3 months
- •Patient who is pregnant or breastfeeding.
结局指标
主要结局
To describe the clinical impact (seizure freedom for 12 months) of Clobazam (Frisium®) as an adjunct therapy in patients who are not adequately stabilized with their anticonvulsant monotherapy.
时间窗: Time point would be 12 months for both primary and secondary outcome
次要结局
- 1. To evaluate safety of Frisium®(2. To evaluate the reasons for adding Frisium®)