A Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults with Focal Seizures

Trial status: Authorised Change from baseline in seizure frequency from the Observation Period to the Treatment Period as assessed across the vormatrigine 20 mg, 30 mg and 40 mg dose groups, Seizure Freedom, during the last period, Time to achieve 50% seizure reduction from the Observation Period, Change from baseline in monthly focal seizure frequency from the Observation Period to each month of the Treatment Period for vormatrigine compared with placebo, Impact of vormatrigine compared to placebo on PGI-C and CGI-C, Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs, Changes in vital sign measurements, Changes in clinical laboratory results, Changes in ECG parameters, Changes in suicidality, as assessed by C-SSRS 50% Responder, defined as at least a 50% reduction in focal seizure frequency from the Observation Period to the Treatment Period

Change from baseline in seizure frequency from the Observation Period to the Treatment Period as assessed across the vormatrigine 20 mg, 30 mg and 40 mg dose groups, Seizure Freedom, during the last period, Time to achieve 50% seizure reduction from the Observation Period, Change from baseline in monthly focal seizure frequency from the Observation Period to each month of the Treatment Period for vormatrigine compared with placebo, Impact of vormatrigine compared to placebo on PGI-C and CGI-C, Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs, Changes in vital sign measurements, Changes in clinical laboratory results, Changes in ECG parameters, Changes in suicidality, as assessed by C-SSRS

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 60 participants