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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00908349 | Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy | PHASE3 | COMPLETED | 214 | — | — | Jun 1, 2009 | Nov 1, 2011 | May 31, 2017 | 58 | United States, Bulgaria +6 |
Measured as change from baseline to end of study
| Arm | Type | Description |
|---|---|---|
| Oxcarbazepine XR | OTHER | Open Label Study |
| Name | Type | Description |
|---|---|---|
| Oxcarbazepine XR | DRUG | Open Label Study |
Inclusion Criteria 1. Able to provide written informed consent and agree to comply with study procedures. 2. Male or female aged 18 to 66 years, inclusive. 3. Successful completion of the 804P301 study. 4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication...