Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
研究概览
地位
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
注册 (实际的)
联系人和位置
学习地点
-
-
New York
-
Brooklyn、New York、美国、11203
- SUNY Downstate Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
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
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
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.