Vormatrigine for Epilepsy

(POWER2 Trial)

Recruiting at 6 trial locations

Overseen By Senior Medical Director Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Praxis Precision Medicines

Must be taking: Antiseizure medications

Must not be taking: Experimental drugs

Disqualifiers: Pseudo seizures, Cluster seizures, Status epilepticus, Drug/alcohol seizures, Others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)

Who Is on the Research Team?

Praxis Precision Medicines

Principal Investigator

Praxis Precision Medicines

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been taking the same anti-seizure medicines for at least 4 weeks.

I have been diagnosed with focal onset epilepsy.

I had at least 4 focal seizures in the last 4 weeks, with no more than 21 days seizure-free.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 20 mg, 30 mg, or 40 mg of vormatrigine or placebo daily for 12 weeks

12 weeks

Regular visits as per trial protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vormatrigine

How Is the Trial Designed?

Group I: 40 mg/day vormatrogine for 12 weeks Experimental Treatment 1 Intervention

Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 40 mg of vormatrogine

Group II: 30 mg/day vormatrogine for 12 weeks Experimental Treatment 1 Intervention

Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 30 mg of vormatrogine

Group III: 20 mg/day vormatrogine for 12 weeks Experimental Treatment 1 Intervention

Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 20 mg of vormatrogine

Group IV: Placebo per day for 12 weeks Placebo Group 1 Intervention

Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive placebo

Who Is Running the Clinical Trial?

Praxis Precision Medicines

Lead Sponsor

Trials

11

Recruited

1,300+