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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00235755 | Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy | PHASE3 | COMPLETED | 539 | — | — | Dec 1, 2005 | Apr 1, 2008 | Apr 21, 2017 | 70 | United States, Australia +11 |
| NCT00232596 | Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy | PHASE3 | COMPLETED | 306 | — | — | Sep 1, 2005 | Jan 1, 2008 | Dec 8, 2016 | 54 | United States, Argentina +3 |
28-day total PS (PSs \[also called focal seizures\] are seizures limited to a specific area of the brain) frequency in the BL period = (Number \[No.\] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = (\[value in the DB period minus value at BL\] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency.
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Retigabine 600 mg | EXPERIMENTAL | - |
| Retigabine 900 mg | EXPERIMENTAL | - |
| Retigabine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Retigabine | DRUG | Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase. |
| Placebo | DRUG | Oral tablet. |
Inclusion Criteria: * Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization * 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase * Currently treated with up to three established AEDs...