Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Alabama
-
Mobile、Alabama、アメリカ
-
-
Arizona
-
Phoenix、Arizona、アメリカ
-
-
California
-
Los Angeles、California、アメリカ
-
-
Colorado
-
Denver、Colorado、アメリカ
-
-
District of Columbia
-
Washington、District of Columbia、アメリカ
-
-
Florida
-
Bradenton、Florida、アメリカ
-
Loxahatchee、Florida、アメリカ
-
Orlando、Florida、アメリカ
-
Pensacola、Florida、アメリカ
-
Tallahassee、Florida、アメリカ
-
Tampa、Florida、アメリカ
-
-
Georgia
-
Atlanta、Georgia、アメリカ
-
Augusta、Georgia、アメリカ
-
-
Illinois
-
Chicago、Illinois、アメリカ
-
-
Louisiana
-
New Orleans、Louisiana、アメリカ
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ
-
-
Minnesota
-
St. Paul、Minnesota、アメリカ
-
-
New Hampshire
-
Lebanon、New Hampshire、アメリカ
-
-
New Jersey
-
Edison、New Jersey、アメリカ
-
Voorhees、New Jersey、アメリカ
-
-
New York
-
Buffalo、New York、アメリカ
-
New York、New York、アメリカ
-
Rochester、New York、アメリカ
-
Syracuse、New York、アメリカ
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ
-
-
Ohio
-
Cleveland、Ohio、アメリカ
-
-
Pennsylvania
-
Hershey、Pennsylvania、アメリカ
-
Philadelphia、Pennsylvania、アメリカ
-
-
South Carolina
-
Charleston、South Carolina、アメリカ
-
-
Tennessee
-
Germantown、Tennessee、アメリカ
-
Nashville、Tennessee、アメリカ
-
-
Texas
-
Fort Worth、Texas、アメリカ
-
Galveston、Texas、アメリカ
-
-
Utah
-
Salt Lake City、Utah、アメリカ
-
-
Virginia
-
Norfolk、Virginia、アメリカ
-
Richmond、Virginia、アメリカ
-
-
West Virginia
-
Morgantown、West Virginia、アメリカ
-
-
Wisconsin
-
Milwaukee、Wisconsin、アメリカ
-
-
-
-
-
Bristol、イギリス
-
Cardiff、イギリス
-
London、イギリス
-
-
-
-
-
Calambrone、イタリア
-
Genoa、イタリア
-
Milano、イタリア
-
Roma、イタリア
-
-
-
-
-
Hyderabad、インド
-
Lucknow、インド
-
Mahim Mumbai、インド
-
Mumbai、インド
-
Pune Maharashtra、インド
-
-
-
-
British Columbia
-
Vancouver、British Columbia、カナダ
-
-
Ontario
-
Thornhill、Ontario、カナダ
-
Toronto、Ontario、カナダ
-
-
-
-
-
Brno、チェコ共和国
-
Praha 4、チェコ共和国
-
-
-
-
-
Berlin、ドイツ
-
Erlangen、ドイツ
-
Heidelberg、ドイツ
-
Jena、ドイツ
-
Kiel、ドイツ
-
-
Kork
-
Kehl、Kork、ドイツ
-
-
-
-
-
Budapest、ハンガリー
-
-
-
-
-
Lille Cedex、フランス
-
Paris、フランス
-
Strasbourg Cedex、フランス
-
-
-
-
-
Campinas、ブラジル
-
Curitiba、ブラジル
-
Porto Alegre、ブラジル
-
Ribeirao Preto、ブラジル
-
Rio de Janeiro、ブラジル
-
Sao Paulo、ブラジル
-
-
-
-
-
Brussels、ベルギー
-
Leuven、ベルギー
-
-
-
-
-
Gdansk、ポーランド
-
-
-
-
-
Mexico City、メキシコ
-
-
-
-
-
Bucharest、ルーマニア
-
Cluj-Napoca、ルーマニア
-
Tirgu-Mures、ルーマニア
-
-
-
-
-
Kalingrad、ロシア連邦
-
Moscow、ロシア連邦
-
St Petersburg、ロシア連邦
-
St. Petersburg、ロシア連邦
-
-
-
-
-
Cape Town、南アフリカ
-
Capitol Park、南アフリカ
-
Johannesburg、南アフリカ
-
-
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
説明
Inclusion Criteria:
- Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit
Exclusion Criteria:
- Patients on a ketogenic diet
- Seizures too close together to accurately count
- Pseudoseizures
- Status epilepticus 1 month prior Visit 1
- Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.
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
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:レベチラセタム
|
Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
他の名前:
|
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 |
---|---|---|
Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
時間枠:Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
|
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
時間枠:Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
|
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
時間枠:Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
|
Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
時間枠:Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
|
Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
時間枠:Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
|
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
時間枠:Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
|
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
|
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
時間枠:Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)
|
The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week. Note: Rates were reported as percentages. |
Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)
|
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
時間枠:Subjects with up to 24 weeks of exposure
|
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
|
Subjects with up to 24 weeks of exposure
|
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
時間枠:Subjects with greater than 24 weeks of exposure
|
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
|
Subjects with greater than 24 weeks of exposure
|
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
時間枠:Subjects with up to 24 weeks of exposure
|
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
|
Subjects with up to 24 weeks of exposure
|
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
時間枠:Subjects with greater than 24 weeks of exposure
|
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
|
Subjects with greater than 24 weeks of exposure
|
Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
時間枠:greater than or equal to 24 weeks, greater than or equal to 40 weeks
|
The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period. The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks. |
greater than or equal to 24 weeks, greater than or equal to 40 weeks
|
Percent of Subjects With Each Seizure Type During the Evaluation Period
時間枠:Evaluation period (48 weeks)
|
Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions). Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions). Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions). A subject could experience more than one seizure type. |
Evaluation period (48 weeks)
|
Investigator Global Evaluation Scale
時間枠:End of Evaluation period (week 48 or at point of early discontinuation)
|
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
|
End of Evaluation period (week 48 or at point of early discontinuation)
|
Parent/Guardian Global Evaluation Scale
時間枠:End of Evaluation period (week 48 or at point of early discontinuation)
|
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
|
End of Evaluation period (week 48 or at point of early discontinuation)
|
Subject (>=8 Years Old) Global Evaluation Scale
時間枠:End of Evaluation period (week 48 or at point of early discontinuation)
|
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
|
End of Evaluation period (week 48 or at point of early discontinuation)
|
Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
時間枠:Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
|
The Leiter-R AM battery has 10 subtests.
The raw scores of the subtests are converted into scaled scores.
Six composite scores are constructed from the 10 subtest scaled scores.
The Memory Screen is one of them.
It is composed of 2 subtests the Associated Pairs and Forward Memory.
The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15).
Higher scores and positive changes from baseline are better.
The range of the Memory Screen composite score is 44 to 155.
|
Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
|
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
時間枠:Visit 5 (Week 24)
|
This score is obtained from a total raw score which is the sum of a battery of individual questions.
It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69).
Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
|
Visit 5 (Week 24)
|
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
時間枠:Visit 7 (week 48)
|
This score is obtained from a total raw score which is the sum of a battery of individual questions.
It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69).
Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
|
Visit 7 (week 48)
|
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
時間枠:Visit 5 (week 24)
|
This score is obtained from a total raw score which is the sum of a battery of individual questions.
It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69).
Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
|
Visit 5 (week 24)
|
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
時間枠:Visit 7 (week 48)
|
This score is obtained from a total raw score which is the sum of a battery of individual questions.
It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69).
Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
|
Visit 7 (week 48)
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:UCB Clinical Trial Call Center、+1 877 822 9493
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
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。
levetiracetam (LEV)の臨床試験
-
Programme National de Lutte contre l'Onchocercose...完了
-
Rosenfeld, William E., M.D.UCB Biopharma S.P.R.L.; PRA Health Sciences; Utrecht University; Comprehensive Epilepsy Care Center...完了
-
Page B. Pennell, MDEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)募集