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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00772603 | Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures | PHASE3 | COMPLETED | 366 | — | — | Nov 1, 2008 | Nov 1, 2010 | Feb 11, 2014 | 71 | United States, Bulgaria +6 |
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH\[T\]), Intent-to-Treat population.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo - four identical tablets taken orally once daily |
| 2400 mg SPN-804 | ACTIVE_COMPARATOR | 2400mg OXC XR taken orally once daily as four identical tablets |
| 1200mg SPN-804 | ACTIVE_COMPARATOR | 1200mg OXC XR taken orally once daily as four identical tablets |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Non-active tablet identical to study drug tablets |
| 2400mg SPN-804 | DRUG | tablets containing 600mg OXC XR, identical to non-active tablets |
| 1200mg SPN-804 | DRUG | two active tablets and two non-active tablets, all identical |
Inclusion Criteria: * Capable of complying with the study procedures. * Able to provide written informed consent * Male or female aged 18 to 65 years, inclusive. * Diagnosis of partial onset seizures * Minimum of three seizures per 28 days * Receiving treatment with 1-3 AEDs * Refractory to at leas...