PRAX-628 for Partial Seizures

(POWER1 Trial)

Recruiting at 21 trial locations

Overseen By Head of Pharmacovigilance

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Praxis Precision Medicines

Disqualifiers: Schizophrenia, Cardiac disease, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

230 Participants Needed

Trial Summary

What is the purpose of this trial?

A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)

Research Team

Medical Director

Principal Investigator

Praxis Precision Medicines

Eligibility Criteria

Adults with focal onset epilepsy, confirmed by CT or MRI to not have a progressive cause, can join this trial. They must not be pregnant, planning pregnancy soon, or breastfeeding. Participants should not have HIV, hepatitis B/C, serious mental health disorders, recent severe seizures requiring hospitalization, or a history of certain malignancies.

Inclusion Criteria

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

I have been diagnosed with focal onset epilepsy.

Exclusion Criteria

Has a positive test result or a known history of a positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody at Screening

Is pregnant or is breastfeeding at the time of Screening or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or within 14 days of the last study drug dose

I am scheduled for epilepsy surgery during the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 20 mg of PRAX-628 or placebo for 6 weeks, followed by 30 mg of PRAX-628 or placebo for the remaining 6 weeks

12 weeks

Visit 1 (Day 1) and subsequent visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PRAX-628

Trial Overview The POWER1 trial is testing PRAX-628's effectiveness and safety in adults with focal seizures. Initially given at 20mg/day for six weeks followed by an increased dose of 30mg/day for another six weeks versus placebo.

Participant Groups

Group I: Randomized, Double-Blind Placebo Experimental Treatment 1 Intervention

Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive a matching placebo throughout the 12-week Treatment Period

Group II: Randomized, Double-Blind 20mg/day for 6 weeks then 30mg/day for remaining 6 weeks PRAX-628 Experimental Treatment 1 Intervention

Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 20 mg of PRAX-628 for 6 weeks followed by 30 mg PRAX 628 for the remaining 6 weeks.

Who Is Running the Clinical Trial?

Praxis Precision Medicines

Lead Sponsor

Trials

11

Recruited

1,300+