Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00646711 | Pediatric Switch Study for Children and Adolescent Patients With Epilepsy | PHASE2 | COMPLETED | 16 | — | — | Feb 1, 2003 | Dec 1, 2003 | Mar 28, 2008 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Sequence Group I | EXPERIMENTAL | Depakote Delayed Release/Depakote Sprinkle |
| Sequence Group II | EXPERIMENTAL | Depakote ER |
| Name | Type | Description |
|---|---|---|
| Depakote Delayed-Release/Depakote Sprinkle | DRUG | Administered according to the subject's usual regimen. |
| Depakote ER | DRUG | Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle. |
Inclusion Criteria: * Male or female patient with a clinical diagnosis of epilepsy considered stable by the investigator. * Must be in good physical health, on the same dose of all medications, including Depakote and other AEDs, for 2 week period prior to randomization. * Minimum body weight of 37 ...