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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00975715 | Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures | PHASE2 | COMPLETED | 99 | — | — | Sep 1, 2009 | Oct 1, 2012 | Jul 16, 2014 | 25 | Japan |
Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.
| Arm | Type | Description |
|---|---|---|
| TRI476 | EXPERIMENTAL | Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage. |
| Name | Type | Description |
|---|---|---|
| TRI476 | DRUG | TRI476 oral suspension doses, based on body weight twice daily |
| Placebo to TRI476 | DRUG | Placebo oral suspension, taken twice daily |
| Benzodiazepines | DRUG | Benzodiazepines could be used as needed as rescue medication during the duration of the study. |
Inclusion Criteria: * Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg. * A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epi...