An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients with Focal Onset or Primary Generalized Tonic-Clonic Seizures

Conditions

Focal onset seizures or primary generalized tonic-clonic seizures

Brief summary

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

Detailed description

Number of days after the first administration of PRAX-628 to reach the same number or higher of monthly seizures from the Screening/Observation Period to the Treatment Period, Impact of PRAX-628 on PGI-S and CGI-S, Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs, Changes in vital signs measurements, Changes in clinical laboratory results, Changes in ECG parameters, Changes in suicidality, as assessed by C-SSRS, Proportion of participants experiencing a ≥50% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX-628, Proportion of participants experiencing seizure freedom, 100% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628

Related papers

No related papers found yet.

Interventions

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) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628	—

Secondary

Measure	Time frame
Number of days after the first administration of PRAX-628 to reach the same number or higher of monthly seizures from the Screening/Observation Period to the Treatment Period, Impact of PRAX-628 on PGI-S and CGI-S, Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs, Changes in vital signs measurements, Changes in clinical laboratory results, Changes in ECG parameters, Changes in suicidality, as assessed by C-SSRS, Proportion of participants experiencing a ≥50% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX-628, Proportion of participants experiencing seizure freedom, 100% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628	—

Measure

Time frame

Number of days after the first administration of PRAX-628 to reach the same number or higher of monthly seizures from the Screening/Observation Period to the Treatment Period, Impact of PRAX-628 on PGI-S and CGI-S, Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs, Changes in vital signs measurements, Changes in clinical laboratory results, Changes in ECG parameters, Changes in suicidality, as assessed by C-SSRS, Proportion of participants experiencing a ≥50% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX-628, Proportion of participants experiencing seizure freedom, 100% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628

—

Countries

Germany, Spain

Outcome results

None listed