Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Retigabine
Retigabine/ Ezogabine · 3 trials · 2 indications
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.
Pharmacokinetic parameters
Pharmacokinetic parameters
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Retigabine 600 mg | EXPERIMENTAL | - |
| Retigabine 900 mg | EXPERIMENTAL | - |
| Retigabine | EXPERIMENTAL | - |
| Dose-Dialysis | ACTIVE_COMPARATOR | Subjects will be dosed with study drug followed by a scheduled dialysis session |
| Dialysis-Dose | ACTIVE_COMPARATOR | Subjects will be dosed following the completion of their scheduled dialysis session |
| 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. |
| Retigabine / Ezogabine | DRUG | Retigabine / Ezogabine will be available as immediate release tablets of 50 milligrams strength. Subjects will be administered the tablet will 250 milliliters of water |
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...
Retigabine, also known as ezogabine, is used for epilepsy and seizures. It is a small molecule developed by GSK plc (ticker: GSK) as an adjunctive treatment for partial onset refractory seizures in adults. The clinical program includes trials in epilepsy and seizures, with a focus on patients whose seizures are not controlled by other therapies.
Retigabine/ezogabine is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials for this small molecule in epilepsy and seizures, including the Phase 3 efficacy and safety studies and a Phase 1 pharmacokinetic study.
Retigabine/ezogabine has been studied in Phase 1 and Phase 3 clinical trials. The Phase 3 trials evaluated its efficacy and safety for partial onset refractory seizures in epilepsy, while a Phase 1 trial examined the effect of haemodialysis on its pharmacokinetics. All listed trials are completed.
Retigabine/ezogabine has been evaluated in completed clinical trials including NCT00235755, a Phase 3 efficacy and safety trial for partial onset refractory seizures in epilepsy with 539 participants, and NCT00232596, a Phase 3 adjunctive therapy study with 306 participants. A Phase 1 trial, NCT01480609, studied the effect of haemodialysis on its pharmacokinetics in 8 participants.
Yes, retigabine and ezogabine are the same drug. Retigabine is the international nonproprietary name, while ezogabine is the United States adopted name. Both names refer to the same small molecule developed by GSK plc for epilepsy and seizures.