Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Retigabine · 2 trials · 1 indication
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...
Retigabine is an investigational small molecule being studied for the treatment of seizures and epilepsy. It is specifically being evaluated as adjunctive therapy for partial onset refractory seizures in epilepsy, targeting adult patients aged 18 years and older.
Retigabine is a small molecule that acts as a potassium channel opener. It works by enhancing the activity of KCNQ potassium channels in the brain, which helps stabilize neuronal activity and reduce the abnormal electrical discharges that cause seizures.
Retigabine is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company has conducted clinical trials to evaluate the drug's efficacy and safety in patients with epilepsy.
Retigabine is in Phase 3 clinical development. It has completed two Phase 3 trials for partial onset refractory seizures in epilepsy, with a total of 845 patients enrolled across multiple countries. The drug is investigational and has not been approved by regulatory authorities.
Retigabine has completed two Phase 3 trials: NCT00232596 with 306 patients and NCT00235755 with 539 patients, both studying adjunctive therapy for partial onset refractory seizures. A Phase 1 trial, NCT01480609, examined the effect of haemodialysis on the drug's pharmacokinetics in epilepsy patients.
Yes, Retigabine is also known as Ezogabine. The Phase 1 trial NCT01480609 specifically studied the effect of haemodialysis on the pharmacokinetics of Ezogabine/Retigabine and its N-acetyl metabolite, confirming that both names refer to the same drug.