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Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy

The purpose of this study is to determine the effect of lacosamide on mood and quality of life in people with epilepsy.

研究概览

地位

完全的

条件

详细说明

Lacosamide (LCM) was found in phase 3 studies to have good efficacy and tolerability as adjunctive treatment in adult patients with uncontrolled partial onset seizures, with or without secondary generalization. Dose-related adverse drug reactions (ADRs) included dizziness, headache and nausea, but the incidence of reported mood symptoms was similar to placebo. The very low incidence of such events, combined with LCM's unique mechanism of action, suggest that LCM has the potential to be among the few anti-epileptic drugs (AEDs) without clinically significant mood ADRs.

The effects of LCM on mood states (i.e., worsening or improvement) have not been examined with standardized measures. In addition, its effects on quality of life (QOL) have not been explored, although QOL is known to be affected by other AEDs.

The investigators propose to examine the effects of LCM on mood and QOL in a real-world population of adult patients with partial-onset seizures. To the knowledge of the investigators, the proposed study will be the first to examine these domains in a scientifically rigorous fashion in patients treated with LCM. Thus, study results will fill a current knowledge gap, and will provide important information to clinicians and patients when considering LCM treatment.

研究类型

观察性的

注册 (实际的)

60

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

    • New York
      • Brooklyn、New York、美国、11203
        • SUNY Downstate Medical Center

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

17年 及以上 (孩子、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 being treated at epilepsy clinics at SUNY Downstate Medical Center

描述

Inclusion Criteria:

  • At least 17 years old
  • Have partial (focal) onset seizures that are not controlled with medication
  • (LCM group only) LCM is being added to anti-epileptic drug regimen by treating physician

Exclusion Criteria:

  • Have taken LCM in the past.
  • Change in anti-epileptic drugs or their doses in the past 28 days.
  • Have participated in another drug research study in the past 3 months.
  • Have had epilepsy brain surgery, or plan to have epilepsy surgery in the next four months.
  • Have a psychiatric or behavioral condition, which in the opinion of the investigator, could compromise patient's ability to participate in the study.
  • Have a progressive (worsening) disease that affects patients brain and its functions.

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

队列和干预

团体/队列
LCM group
Patients who are having lacosamide (LCM) added to their anti-epileptic drug regimen
control group
Patients who are NOT having lacosamide (LCM) added to their anti-epileptic drug regimen

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
大体时间:baseline and 3 months later
baseline and 3 months later
Change from baseline in Profile of Mood States (POMS) score
大体时间:baseline and 3 months later
baseline and 3 months later

次要结果测量

结果测量
大体时间
Change from baseline in QOLIE-89 subtests
大体时间:baseline and 3 months later
baseline and 3 months later
Change from baseline in POMS subtests
大体时间:baseline and 3 months later
baseline and 3 months later

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。

合作者

调查人员

  • 首席研究员:Arthur C Grant, MD, PhD、State University of New York - Downstate Medical Center

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6月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2011年2月9日

首先提交符合 QC 标准的

2011年2月15日

首次发布 (估计)

2011年2月16日

研究记录更新

最后更新发布 (估计)

2015年12月24日

上次提交的符合 QC 标准的更新

2015年12月23日

最后验证

2012年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 11-011

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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