Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy

Exclusion Criteria

• •Subject has a history of or signs of generalized or combined generalized and focal epilepsy
• •Cluster seizures which are uncountable in the previous 8 weeks before study entry and during 4 weeks prospective baseline
• •Current treatment with carbamazepine, phenytoin, primidone, phenobarbital
• •Current treatment/ use of (non-AED) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 or 2C19 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
• •Subjects taking sensitive substrates of CYP2C19 for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
• •Subject has been taking vigabatrin less than 2 years at study entry
• •Subject has been taking felbamate for less than 12 months
• •Subject taking retigabine for less than 4 years
• •Current treatment with benzodiazepines (i.e. GABA-A-ergic drugs like zolpidem, zaleplon, or zopiclone, excluding GABA-A-ergic AEDs) \<3 times per week for emergencies
• •Subject has a current medical condition that occurred within the last 12 months which, in the opinion of the investigator, could compromise his/her safety or ability to participate in this study