Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
New York
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Brooklyn、New York、アメリカ、11203
- Suny Downstate Medical Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
LCM group
Patients who are having lacosamide (LCM) added to their anti-epileptic drug regimen
|
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control group
Patients who are NOT having lacosamide (LCM) added to their anti-epileptic drug regimen
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
時間枠：baseline and 3 months later
|
baseline and 3 months later
|
|
Change from baseline in Profile of Mood States (POMS) score
時間枠：baseline and 3 months later
|
baseline and 3 months later
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from baseline in QOLIE-89 subtests
時間枠：baseline and 3 months later
|
baseline and 3 months later
|
|
Change from baseline in POMS subtests
時間枠：baseline and 3 months later
|
baseline and 3 months later
|
協力者と研究者
協力者
捜査官
- 主任研究者：Arthur C Grant, MD, PhD、State University of New York - Downstate Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。