NCT02276053已完成不适用
A Noninterventional Study of Vimpat® (Lacosamide) as Adjunctive Antiepileptic Drug Therapy in Patients With Brain Tumor-related Epilepsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 24
- 主要终点
- Percentage of Patients With Response at the End of the 6-month Observation Period
研究概览
简要总结
This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has never been treated with lacosamide (LCM) prior to this non-interventional study (NIS) or treatment with LCM for the first time started no earlier than 7 days prior to enrollment in this NIS
- •The decision by the treating physician to prescribe LCM falls within current standard clinical practice, and the treatment decision is clearly separated from the decision to consider inclusion of the patient in the NIS
- •A Patient Data Consent form is signed and dated by the patient and/or by the parent(s) or legal representative
- •Patient is a male or female ≥ 16 years of age
- •Patient must have a diagnosis of brain tumor-related epilepsy (BTRE) secondary to low-grade glioma (World Health Organization Grade 1 to 2 at time of enrollment)
- •Patient has a retrospective Baseline seizure frequency of at least 1 partial-onset seizure in the 8 weeks prior to Visit 1 (enrollment/ Baseline visit)
- •Patient does not have a previous diagnosis of epilepsy before tumor onset
- •Patient does not have brain metastases
- •Patient has a Karnofsky performance status scale index ≥ 60 %
- •Patient is currently taking only 1-2 Baseline anti-epileptic drugs (AEDs) for epilepsy, other than LCM
- •Patient has received a maximum of 4 different lifetime AEDs ever before entering the NIS
排除标准
- 未提供
结局指标
主要结局
Percentage of Patients With Response at the End of the 6-month Observation Period
时间窗: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
A responder is a patient experiencing a 50 % or greater reduction in partial onset seizure frequency from Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Patient Global Impression of Change (PGIC) Rating at Visit 3
时间窗: Visit 3 (Month 6 or end of Observation Period)
The Patient Global Impression of Change scale is a seven-point scale for patients to rate their general health status at the end of the study compared to how they felt before entering the study. Scores 1 to 3 mean improvement, score 4 means no change, and scores 5 to 7 mean worsening. The category 'Improved' represents the sum of Very Much Improved, Much Improved, and Minimally Improved. The category 'Worsened' represents the sum of Minimally Worse, Much Worse, and Very Much Worse.
次要结局
- Percentage of Patients With Seizure-free Status (Yes/No) at the End of the 6-month Observational Period(Visit 3 (Month 6 or end of Observation Period))
- Percentage of Patients With Retention on Lacosamide (LCM) at the End of the 6-month Observation Period(Visit 3 (Month 6 or end of Observation Period))
- Time to Discontinuation of Lacosamide (LCM) Treatment From the Date of First Dose of LCM(From first dose to discontinuation, over a 6-month Observation Period)
- Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the 5 Level EuroQol-5 Dimension Quality of Life Assessment (EQ-5D-5L) Visual Analogue Scale (VAS) Score(Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period))
- Actual Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in Seizure Frequency (Seizures Per 28 Days)(Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period))
- Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the 5 Level EuroQol-5 Dimension Quality of Life Assessment (EQ-5D-5L) Change in Utility as Converted From the 5 Dimensions(Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period))
- Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)(Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period))
- Percentage Change From Baseline in Seizure Frequency(Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period))
- Discontinuation Rate of Lacosamide (LCM) Due to Adverse Drug Reactions (ADRs)(Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period))
- Clinical Global Impression of Change (CGIC) Rating at Visit 3 (Month 6 or End of Observation Period)(Visit 3 (Month 6 or end of Observation Period))
- Discontinuation Rate of Lacosamide (LCM) Due to Lack of Effectiveness(Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period))
研究者
研究点 (24)
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