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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00918047 | Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients | PHASE1 | COMPLETED | 18 | — | — | Jun 1, 2009 | Nov 1, 2010 | Jul 2, 2017 | 8 | United States |
| Arm | Type | Description |
|---|---|---|
| SPN-804O 150mg/Day | EXPERIMENTAL | Subjects who weighed 15.0 to 29.9 kg dosed with SPN-804O 150mg/Day |
| SPN-8040 300mg/Day | EXPERIMENTAL | Subjects who weighed 30.0 to 44.9 kg dosed with SPN-8040 300mg/Day |
| SPN-8040 450mg/Day | EXPERIMENTAL | Subjects who weighed 45.0 to 59.9 kg dosed with SPN-8040 450mg/Day |
| SPN-8040 600mg/Day | EXPERIMENTAL | Subjects who weighed 60.0 kg and above dosed with SPN-8040 600mg/Day |
| Name | Type | Description |
|---|---|---|
| SPN-804O | DRUG | Open Label study |
Inclusion Criteria: 1. Able to provide written informed assent (IAF), as appropriate, with written informed permission (and informed consent (ICF) where required by regional laws or regulations) from the parent or legally-authorized representative (LAR). 2. Male or female aged 4 to 17 years, inclus...