A Pharmacogenomic Exploration of Lacosamide Response
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 660
- 试验地点
- 5
- 主要终点
- Seizure frequency
研究概览
简要总结
This is an observational study exploring the genetics of lacosamide response. The study will last 3 years and has been divided in to three stages; 1) recruitment, 2) observational phase, 3) genotyping and analysis. Patients initiating lacosamide are recruited and their baseline seizure frequency is assessed retrospectively. Patients are then monitored for 18 months with an assessment (via interview and where possible seizure diaries) of seizure frequency and other treatment related phenotypes every 3 months. The recruitment period will span months 1-12, the observational period will span months 1-30 and analysis of data will be conducted between months 30-36 (see Figure 2 below). Target sample size is 610.
Primary objective: To determine the clinical relevance of genetic variation in predicting lacosamide responsive and non-responsive patients.
Secondary objectives: To determine the clinical relevance of genetic variation in predicting:
- Optimal dose of lacosamide
- Adverse drug reactions to lacosamide
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with partial onset seizures (simple and/or complex) with or without secondary generalization (based on 1981 ILAE seizure classification scheme)
- •Over 18 and under 65 years of age at date of recruitment in to the study
- •Currently undergoing pharmacological treatment for refractory partial epilepsy ('refractory' here refers to patients who continue to have seizures despite treatment (current) with two or more appropriate anti-epileptic drugs at appropriate doses)
- •Deemed suitable for treatment with lacosamide (following drug guidelines)
排除标准
- •Patients experiencing seizure type other than partial onset seizures (with/without secondary generalisation)
- •Patients with a history of chronic alcohol or drug abuse within previous 3 years.
- •Non refractory epilepsy patients
- •Patients suffering any other clinically significant disease e.g. cancers, progressive neurological disorder, heart failure, respiratory failure etc
- •Patients who are pregnant or who are intending on getting pregnant within the period of the trial.
结局指标
主要结局
Seizure frequency
时间窗: Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period
We will record seizure type and frequency. Seizure types will follow definitions as provided by the International League Against Epilepsy. Seizure frequency will be as recorded by the participant in a seizure diary.
次要结局
- Maintenance dose(Recorded every three months for an 18 month period)
- Adverse drug reactions(Recorded as reaction arise during the 18 month study period)
研究者
Norman Delanty
Consultant Neurologist
Royal College of Surgeons, Ireland