A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety & Efficacy of Perampanel in Indian Patients as an Adjunctive Treatment inPartial Onset Seizures with or Without Secondary Generalized Seizures in Patients with Epilepsy Aged 12 years or older.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- of age 12 years and older with epilepsy.
研究概览
简要总结
Prospective, multicenter, open label, non-comparative, post-marketing surveillance study to evaluate safety & efficacy of perampanel as adjunctive therapy in patients with partial onset seizures with or with secondary generalized seizure of age 12 years and older.
Up-to 200 Indian patients across 10 centers from India will be enrolled to receive perampanel based on independent clinical judgment of treating physicians/Principle Investigator as per the approved Package Insert in India. Once enrolled, patients will be observed prospectively for a period of 6 months or till the patients withdraw from the study (for either lack of efficacy or intolerance or the patient is lost to follow up) whichever is earlier. Seizure diaries will be issued to the patients.
The study will consist of Screening and Enrolment Visit (Day 1) and Treatment Period (6 months). For each participant, visits during the Treatment Period will be conducted each month.
Participants will be monitored during the treatment of perampanel for 6 months & up to 30 days post treatment period of 6 months in case of SAE or till the patients’ withdrawal from the study for collection of adverse events.
Participants’ safety will be monitored throughout the study.
The total duration of the study will be 12 months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients age greater than or equal to 12 years at the time of informed consent
- •Patients prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians.
- •Patients who provide informed consent to the treating physician.
排除标准
- •Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
- •Hypersensitivity [allergic] to perampanel.
结局指标
主要结局
of age 12 years and older with epilepsy.
时间窗: 6 Months
To assess the safety of perampanel in the treatment of partial onset seizures in patients
时间窗: 6 Months
次要结局
- ô€¸ To assess the change in seizure frequency with perampanel as adjunctive treatment of(partial onset seizures in patients of age 12 years and older with epilepsy)