A Pharmacogenomic Exploration of Lacosamide Response
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
調査の概要
状態
条件
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Dublin、アイルランド、D4
- 募集
- Beaumont Hospital
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コンタクト：
- Gianpiero Cavalleri, PhD
- 電話番号：+353 1 4022146
- メール：gcavalleri@rcsi.ie
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主任研究者：
- Norman Delanty
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Dublin、アイルランド
- 募集
- St.James Hospital
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コンタクト：
- Colin Doherty
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North Carolina
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Durham、North Carolina、アメリカ
- 募集
- Duke Medical Centre
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コンタクト：
- Saraubh Sinha
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London、イギリス
- 募集
- The Institute of Neurology
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コンタクト：
- Sanjay Sisodiya
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Brussels、ベルギー
- 募集
- Hospital Erasme
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コンタクト：
- Chantal Depondt
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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:
- 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.
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 |
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Beaumont Hospital, Dublin, Ireland
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St. James' Hospital, Dublin, Ireland
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Hôpital Erasme, Brussels, Belgium
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Duke Medical Centre, North Carolina, USA
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The Institute of Neurology/University College London, UK
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Seizure frequency
時間枠：Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period
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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.
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Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maintenance dose
時間枠：Recorded every three months for an 18 month period
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Maintenance dose will be defined as the tolerated daily dose required by the patient for seizure control.
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Recorded every three months for an 18 month period
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Adverse drug reactions
時間枠：Recorded as reaction arise during the 18 month study period
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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.
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Recorded as reaction arise during the 18 month study period
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協力者と研究者
協力者
捜査官
- 主任研究者：Norman Delanty, MB FRCPI、Beaumont Hospital and Royal College of Surgeons in Ireland
- 主任研究者：Gianpiero L Cavalleri, PhD、Royal College of Surgeons in Ireland
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
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