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

Conditions

Focal Epilepsy

Brief summary

50% Responder, defined as at least a 50% reduction in focal seizure frequency from the Observation Period to the Treatment Period

Detailed description

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

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Interventions

DRUGPlacebo for PRAX-628

DRUGPRAX-628

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
50% Responder, defined as at least a 50% reduction in focal seizure frequency from the Observation Period to the Treatment Period	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Outcome results

None listed