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A Pharmacogenomic Exploration of Lacosamide Response

2012年12月5日更新者：Norman Delanty、Royal College of Surgeons, Ireland

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

研究概览

地位

未知

条件

癫痫

研究类型

观察性的

注册 (预期的)

660

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

比利时
- - Brussels、比利时
    - 招聘中
    - Hospital Erasme
    - 接触：
      
      Chantal Depondt
爱尔兰
- - Dublin、爱尔兰、D4
    - 招聘中
    - Beaumont Hospital
    - 接触：
      
      Gianpiero Cavalleri, PhD
      
      电话号码：+353 1 4022146
      
      邮箱：gcavalleri@rcsi.ie
    - 首席研究员：
      
      Norman Delanty
  - Dublin、爱尔兰
    - 招聘中
    - St.James Hospital
    - 接触：
      
      Colin Doherty
美国
- North Carolina
  - Durham、North Carolina、美国
    - 招聘中
    - Duke Medical Centre
    - 接触：
      
      Saraubh Sinha
英国
- - London、英国
    - 招聘中
    - The Institute of Neurology
    - 接触：
      
      Sanjay Sisodiya

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

patients with epilepsy recruited from five tertiary referral centres.

描述

Inclusion Criteria:

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)

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Beaumont Hospital, Dublin, Ireland
St. James' Hospital, Dublin, Ireland
Hôpital Erasme, Brussels, Belgium
Duke Medical Centre, North Carolina, USA
The Institute of Neurology/University College London, UK

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Seizure frequency 大体时间：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.	Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period

次要结果测量

结果测量	措施说明	大体时间
Maintenance dose 大体时间：Recorded every three months for an 18 month period	Maintenance dose will be defined as the tolerated daily dose required by the patient for seizure control.	Recorded every three months for an 18 month period
Adverse drug reactions 大体时间：Recorded as reaction arise during the 18 month study period	We will record any adverse reactions recorded by the study participant, including for example (but not limited to): dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and vision blurred.	Recorded as reaction arise during the 18 month study period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Royal College of Surgeons, Ireland

合作者

Duke University

University College, London

St. James's Hospital, Ireland

Erasme University Hospital

调查人员

首席研究员：Norman Delanty, MB FRCPI、Beaumont Hospital and Royal College of Surgeons in Ireland
首席研究员：Gianpiero L Cavalleri, PhD、Royal College of Surgeons in Ireland

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年9月1日

初级完成 (预期的)

2014年3月1日

研究完成 (预期的)

2014年3月1日

研究注册日期

首次提交

2011年7月20日

首先提交符合 QC 标准的