A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy.
Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
Subject has had any of the of the following within the 12-month period preceding trial entry: History of pseudo or psychogenic seizures, cluster seizures where the individual seizures cannot be counted, an episode of convulsive status epilepticus requiring hospitalization and intubation, or subject only has focal seizures with awareness that do not have motor activity.
Planned epilepsy surgery during the course of the clinical trial.
History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment or vagus nerve stimulation (VNS) implantation.
History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders.
Parallel
20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
DrugOnce daily oral
Placebo
DrugOnce 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.
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.
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.
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
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
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