Interventional randomized double-blind crossover placebo controlled exploratory phase Ib study investigating the safety tolerability pharmacokinetic and electrocorticographic response of Lu AG06466 in treatment resistant focal epilepsy patients with chronically implanted responsive neurostimulation system (RNS System).

Brief description of study

The purpose of this study is to find out about the safety and efficacy (how well something works) of Lu AG06466 for the treatment of epilepsy. Lu AG06466 is an experimental drug, which means it is not approved by Health Authorities, including the United States Food and Drug Administration (FDA), for the treatment of epilepsy. Seizure episodes are a result of excessive electrical discharges in the brain, which can be long-lasting or frequent. Lu AG06466 has been designed to reduce excessive electrical discharge and inflammation of the nervous tissue in the brain. It is being investigated to see if it can safely decrease seizure activity in epilepsy patients for which standard seizure medications have failed.


Clinical Study Identifier: s21-00755
ClinicalTrials.gov Identifier: NCT05081518
Principal Investigator: Daniel Friedman.


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