NCT04257604已完成不适用
A Multicenter, Prospective, Real-life Observational Study of Perampanel as Add-on Therapy in Adult and Adolescent Patients With Focal Seizures (A Mirroring Clinical Practice Study of Perampanel in Adults and Adolescents) (The AMPA Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 主要终点
- Percentage Change From Baseline in all Seizures Frequency at Month 6
研究概览
简要总结
The primary objective of the present study will be to assess the effectiveness of add-on perampanel in participants with focal seizures in a real-life clinical setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescribe perampanel according to the approved indication
- •Participants with focal seizures with or without secondary generalization
- •Participants with seizure frequency data available at the baseline visit
- •Based on the physician's clinical judgment, the participant seizure activity is not controlled sufficiently with the current treatment with 1-3 AEDs and it is in the participants best interest to be prescribed adjunctive perampanel
- •The decision to prescribe perampanel is made by the physician before and independently of his/her decision to include the participant in the study
- •Treatment with perampanel is not yet started before baseline
排除标准
- •Participants contraindicated for perampanel use (according to SmPC)
- •Participants with moderate to severe renal impairment
- •Participants with severe hepatic impairment
- •Pregnant or lactating women
- •Participants suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation
研究组 & 干预措施
Perampanel
Participants with partial-onset seizures, with or without secondary generalization will receive perampanel tablets as add-on therapy according to the approved summary of product characteristics (SmPC) after the baseline visit as part of the clinical practice and will be observed after 3 months (visit 1), 6 months (visit 2), and 12 months (final visit).
干预措施: Perampanel (Drug)
结局指标
主要结局
Percentage Change From Baseline in all Seizures Frequency at Month 6
时间窗: Baseline, Month 6
Seizure frequency is derived from information (seizure count and type) recorded in participant diary. Seizure frequency is based on the number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28.
次要结局
- Percentage of Participants Remaining on Perampanel at Months 6 and 12(Months 6 and 12)
- Percentage of Participants With at Least 50 Percent (%) and 75% Reduction From Baseline in All Seizure Frequency at Months 3, 6 and 12(Baseline, Months 3, 6, and 12)
- Percentage of Participants Who Were Seizure-free(Up to Month 12)
- Mean Change From Baseline in Irritability With Epilepsy Questionnaire Score (I-Epi) in Adult Participants at Months 3, 6, and 12(Baseline, Months 3, 6, and 12)
- Percentage of Participants With Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs)(Up to Month 12)
- Mean Change From Baseline in Epworth Sleepiness Scale (ESS) Score in Adult Participants at Months 3, 6, and 12(Baseline, Months 3, 6, and 12)
- Regression Coefficient For Predictive Factors in Response to Perampanel(Up to Month 12)
- Percentage of Participants Who Withdraw due to ADR(Up to Month 12)
- Percentage of Participants Who Withdraw due to Lack of Efficacy(Up to Month 12)
- Mean Change From Baseline in the Number of Concomitant Anti-epileptic Drugs (AEDs)(Baseline up to Month 12)
- Percentage of Participants With at Least 50% and 75% Reduction From Baseline in Secondarily Generalized Tonic-clonic Seizures (SGTCS) Frequency at Months 3, 6 and 12(Baseline, Months 3, 6, and 12)
- Median Percentage Change From Baseline in SGTCS Frequency at Months 3, 6 and 12(Baseline, Months 3, 6, and 12)
- Median Percentage Change From Baseline in All Seizure Frequency at Months 3 and 12(Baseline, Months 3 and 12)
- Mean Change From Baseline in 31-item Quality of Life in Epilepsy (QOLIE-31) Questionnaire Score in Adult Participants at Month 6 and 12(Baseline, Months 6 and 12)
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