A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults with Focal Seizures (POWER 1)

Conditions

Focal Epilepsy

Brief summary

Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared to placebo.

Detailed description

Proportion of participants experiencing a ≥50% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX-628 compared to placebo., Number of days post-randomization to reach the same number of monthly focal seizures as the Screening/Observation Period through the end of the Treatment Period • Impact of PRAX-628 compared to placebo on PGI-S and CGI-S, 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, Percent change in monthly focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared with placebo., Proportion of participants experiencing seizure freedom, 100% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared with placebo.

Related papers

No related papers found yet.

Interventions

DRUGPlacebo for PRAX-628

DRUGPRAX-628

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared to placebo.	—

Secondary

Measure	Time frame
Proportion of participants experiencing a ≥50% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX-628 compared to placebo., Number of days post-randomization to reach the same number of monthly focal seizures as the Screening/Observation Period through the end of the Treatment Period • Impact of PRAX-628 compared to placebo on PGI-S and CGI-S, 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, Percent change in monthly focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared with placebo., Proportion of participants experiencing seizure freedom, 100% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatmen	—

Measure

Time frame

Proportion of participants experiencing a ≥50% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX-628 compared to placebo., Number of days post-randomization to reach the same number of monthly focal seizures as the Screening/Observation Period through the end of the Treatment Period • Impact of PRAX-628 compared to placebo on PGI-S and CGI-S, 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, Percent change in monthly focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared with placebo., Proportion of participants experiencing seizure freedom, 100% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatmen

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Countries

Italy, Poland, Spain

Outcome results

None listed