A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)
PRAX-628-322 (POWER 2) is a Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Once daily oral
Once daily oral
Once daily oral
Praxis Research Site
Miami, Florida, United States
RECRUITINGPraxis Research Site
Miami Lakes, Florida, United States
RECRUITINGPraxis Research Site
Naples, Florida, United States
To evaluate the efficacy of vormatrigine 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 vormatrogine compared to placebo.
Time frame: 12 weeks
To further evaluate the efficacy of vormatrigine 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 vormatrogine compared to placebo
Time frame: 12 weeks
To assess trends over time in efficacy of vormatrogine on focal seizure frequency
Percent change in monthly focal seizure frequency from the Screening/Observation Period to the Treatment Period for vormatrogine compared with placebo.
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Change in tympanic temperature in Celsius
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Change in heart rate in beats per minute
Time frame: 12 weeks
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Once daily oral
Praxis Research Site
Marlboro, New Jersey, United States
RECRUITINGPraxis Research Site
Niagara Falls, New York, United States
RECRUITINGPraxis Research Site
Raleigh, North Carolina, United States
RECRUITINGPraxis Research Site
Houston, Texas, United States
RECRUITINGTo assess the safety and tolerability of vormatrigine in adults with focal seizures
Change in blood pressure in mm/Hg
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Change in respiratory rate in breaths per minute
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine 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 vormatrigine in adults with focal seizures
Incidence of clinically significant ECG abnormalities
Time frame: 12 weeks
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Changes in suicidality, as assessed by C-SSRS
Time frame: 12 weeks