A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
PRAX-628-321 (POWER1) is a double-blind, randomized, multicenter, trial to evaluate the efficacy and safety of PRAX-628 in adults who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
255
Once daily oral
Once daily oral
To evaluate the efficacy of PRAX-628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
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.
Time frame: 12 weeks
To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
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.
Time frame: 12 weeks
To assess trends over time in efficacy of PRAX 628 on focal seizure frequency
Percent change in monthly focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared with placebo.
Time frame: 12 weeks
To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
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 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 Impact of PRAX-628 compared to placebo on PGI-S and CGI-S
Time frame: 12 weeks
To assess the safety and tolerability of PRAX-628 in adults with focal seizures
Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs
Time frame: 12 weeks
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Praxis Research Site
Phoenix, Arizona, United States
Praxis Research Site
Loma Linda, California, United States
Praxis Research Site
DeLand, Florida, United States
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Miami, Florida, United States
Praxis Research Site
Miami Lakes, Florida, United States
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Naples, Florida, United States
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Orlando, Florida, United States
Praxis Research Site
Chicago, Illinois, United States
Praxis Research Site
Lafayette, Louisiana, United States
Praxis Research Site
Bethesda, Maryland, United States
...and 59 more locations
To assess the safety and tolerability of PRAX-628 in adults with focal seizures
Change in tympanic temperature in Celsius
Time frame: 12 weeks
To assess the safety and tolerability of PRAX-628 in adults with focal seizures
Change in heart rate in beats per minute
Time frame: 12 weeks
To assess the safety and tolerability of PRAX-628 in adults with focal seizures
Change in blood pressure in mm/Hg
Time frame: 12 weeks
To assess the safety and tolerability of PRAX-628 in adults with focal seizures
Change in respiratory rate in breaths per minute
Time frame: 12 weeks
To assess the safety and tolerability of PRAX-628 in adults with focal seizures
The principal investigator (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events.
Time frame: 12 weeks
To assess the safety and tolerability of PRAX-628 in adults with focal seizures
Incidence of clinically significant ECG abnormalities
Time frame: 12 weeks
To assess the safety and tolerability of PRAX-628 in adults with focal seizures
Changes in suicidality, as assessed by C-SSRS
Time frame: 12 weeks