Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
研究概览
简要总结
The purpose of this study is to determine the effect of lacosamide on mood and quality of life in people with epilepsy.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
时间窗: baseline and 3 months later
Change from baseline in Profile of Mood States (POMS) score
时间窗: baseline and 3 months later
次要结局
- Change from baseline in QOLIE-89 subtests(baseline and 3 months later)
- Change from baseline in POMS subtests(baseline and 3 months later)