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To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Group I | Experimental | Depakote Delayed Release/Depakote Sprinkle |
|
| Sequence Group II | Experimental | Depakote ER |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depakote Delayed-Release/Depakote Sprinkle | Drug | Administered according to the subject's usual regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of seizures | 2 weeks | |
| Number of Adverse Events | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond | Virginia | 23284 | United States |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Depakote ER | Drug | Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle. |
|
|
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |