Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution
Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Birmingham、イギリス
- 057
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Liverpool、イギリス
- 052
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London、イギリス
- 051
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Bologna、イタリア
- 037
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Calambrone、イタリア
- 031
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Milano、イタリア
- 032
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Roma、イタリア
- 034
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Verona、イタリア
- 035
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Athens、ギリシャ
- 072
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Patras、ギリシャ
- 071
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Barcelona、スペイン
- 043
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Madrid、スペイン
- 044
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Madrid、スペイン
- 045
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Murcia、スペイン
- 046
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Berlin、ドイツ
- 027
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Bielefeld、ドイツ
- 024
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Heidelberg、ドイツ
- 026
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Kehl Kork、ドイツ
- 021
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Kiel、ドイツ
- 023
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Muenster、ドイツ
- 022
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Amiens、フランス
- 012
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Bron、フランス
- 010
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Paris、フランス
- 011
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Gdansk、ポーランド
- 065
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Lodz、ポーランド
- 064
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Szczecin、ポーランド
- 063
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Warszawa、ポーランド
- 062
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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:
- diagnosis of epilepsy
- being treated with Keppra® Oral Solution
- aged between 1 month and 11 months inclusive at study baseline
Exclusion Criteria:
- none
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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Patients, 1 - 11 months old, prescribed Keppra® oral solution
Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who are between 1 and 11 months old.
The patients will be followed as per current clinical practices for their condition.
The choice of medical treatment, including the concomitant use of other antiepileptic drugs, is made independently by the physician in the regular course of practice and is not influenced by the study protocol.
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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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Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
時間枠:From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
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From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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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 |
---|---|---|
Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up
時間枠:From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
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Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
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From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
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Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit
時間枠:From Baseline through the last Treatment Visit (maximum 12 months)
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Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).
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From Baseline through the last Treatment Visit (maximum 12 months)
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Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit
時間枠:From Baseline to the last Treatment Visit (maximum 12 months)
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Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months).
The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient.
The evaluation of the patient's psychomotor development was categorized by the motor development, the social development and the language development.
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From Baseline to the last Treatment Visit (maximum 12 months)
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Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit
時間枠:From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
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For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores.
For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.
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From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
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Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit
時間枠:From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores.
For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.
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From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit
時間枠:From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores.
For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.
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From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit
時間枠:From Baseline to the last Treatment Visit (maximum 12 months)
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Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs). The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs. |
From Baseline to the last Treatment Visit (maximum 12 months)
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Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit
時間枠:From Baseline to the last Treatment Visit (maximum 12 months)
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The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.
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From Baseline to the last Treatment Visit (maximum 12 months)
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Global Evaluation Scale of the Psychomotor Development (GES)
時間枠:From Baseline to the last Treatment Visit (maximum 12 months)
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Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options: 7=Marked improvement 6=Moderate improvement 5=Slight improvement 4=No Change 3=Slight worsening 2=Moderate worsening 1=Marked worsening As a variant of this variable, a 3-class variable was derived as follows
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From Baseline to the last Treatment Visit (maximum 12 months)
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Global Evaluation Scale of Epilepsy Severity (GES)
時間枠:From Baseline to the last Treatment Visit (maximum time frame is 12 months)
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Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options: 7=Marked improvement 6=Moderate improvement 5=Slight improvement 4=No Change 3=Slight worsening 2=Moderate worsening 1=Marked worsening As a variant of this variable, a 3-class variable was derived as follows
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From Baseline to the last Treatment Visit (maximum time frame is 12 months)
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Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period
時間枠:From Baseline through the last Treatment Visit (maximum 12 months)
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Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).
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From Baseline through the last Treatment Visit (maximum 12 months)
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協力者と研究者
スポンサー
出版物と役立つリンク
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
本研究に関する用語
その他の研究ID番号
- N01357
- 2009-017333-21 (EudraCT番号)
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