Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population
調査の概要
詳細な説明
Participants will initially be consented into the study, and receive baseline assessments. At the baseline visit, seizure types (partial, primary generalized, secondary generalized), seizure foci localization, and additional medication treatment status for the duration of the study will be established. IQ status which has been done (either by the school system or as part of a developmental assessment,) will be used.
Behavioral status will be verified and related to seizure activity as well. Behavioral measures will include the Vineland (a measure of life skills assessment) and the Child Behavior Checklist. Participants then return for a study visit two weeks later. At that time initial laboratory tests will be done including a trough level of valproic acid. Pregnancy tests will be done on all females of childbearing potential, because of the known risk of valproic acid during pregnancy. Participants will return for a third study visit two weeks later where another trough valproic acid level will be obtained, and effective dosage conversion of Depakote® Sprinkle to Depakote® ER will occur. Subsequent study visits will occur at weeks 6 and 8 (2 and 4 weeks respectively, after the dose conversion); trough valproic acid levels will be obtained each time. At each study visit, neurologic (seizure control) and behavioral status will be reviewed as well as monitoring for side effects and adverse events. Each study visit will also include instruction and coaching regarding strategies for pill swallowing and other aspects of adherence to treatment regimen. Compliance will be ascertained by means of drug level monitoring pre and post dosage conversion. Clinical global improvement in functioning for both behavioral issues and epilepsy will be assessed.
The study will conclude after the 5th visit.
Table of Events Visit 1 2 3 4 5 Day -28 -14 0 14 28 Week -4 -2 0 2 4 Informed Consent X Eligibility Criteria X X Demographics X Medical and Surgical History X IQ verification X QOLIE X X Vineland X X CBCL X X Seizure assessment X X X X X Physical and Neurologic exam X X X VS X X X Lab assessments X X
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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District of Columbia
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Washington、District of Columbia、アメリカ、20010
- Children's National 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
説明
Inclusion Criteria:
- Age 4-18 years, inclusive.
- Clinical Diagnosis of Partial or Primary Generalized Seizure Disorder
- Documented IQ scores in the range of borderline, mild, moderate, or severe mental retardation (IQ<80).
- Currently Treatment regimen includes Depakote® Sprinkles either as monotherapy or adjunctive therapy. Dosages should have been stable for at least 4 weeks prior to baseline.
- Subject's parent or guardian must be capable of maintaining a record of dosing times, seizure characteristics, and adverse events.
Exclusion Criteria:
- Oral Motor Dysfunction to the degree that swallowing is affected.
- History of significant aspiration.
- Serious medical conditions such as cancer, pancreatitis, diabetes, HIV.
- History of hepatic dysfunction including history of elevated liver enzymes (AST or ALT values greater or equal to three times the upper limit of normal).
- History of metabolic disorders including urea cycle disorders.
Pregnancy
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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）
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 |
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Ability to swallow capsules in a mentally retarted developmentally delayed population
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協力者と研究者
捜査官
- 主任研究者：Joan A Conry, MD、Children's National Research Institute
研究記録日
主要日程の研究
研究開始
研究の完了
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。
Swallow instructionの臨床試験
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