Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT00207935
Eligibility Criteria:
Inclusion Criteria:
1. Age 4-18 years, inclusive.
2. Clinical Diagnosis of Partial or Primary Generalized Seizure Disorder
3. Documented IQ scores in the range of borderline, mild, moderate, or severe mental retardation (IQ\<80).
4. 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.
5. Subject's parent or guardian must be capable of maintaining a record of dosing times, seizure characteristics, and adverse events.
Exclusion Criteria:
1. Oral Motor Dysfunction to the degree that swallowing is affected.
2. History of significant aspiration.
3. Serious medical conditions such as cancer, pancreatitis, diabetes, HIV.
4. 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).
5. History of metabolic disorders including urea cycle disorders.
6. Pregnancy
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT00207935
Study Brief:
Protocol Section:
NCT00207935