Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Retigabine/ Ezogabine · 1 trial · 1 indication
Pharmacokinetic parameters
Pharmacokinetic parameters
| Arm | Type | Description |
|---|---|---|
| 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 / 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: * Male or female 18 years or older, at the time of signing the informed consent. * ESRD patients with minimal or no residual renal function and receiving stabilised haemodialysis regimen. * Body mass index with the range of 18-42 kg/m2 at screening. * A female subject is eligibl...
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.