- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00207935
Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20010
- Children's National Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Ability to swallow capsules in a mentally retarted developmentally delayed population
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Joan A Conry, MD, Children's National Research Institute
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CNMC IRB 3579
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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