Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures

NCT07505004 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: PRAX-628-322
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Focal Epilepsy

Keywords

focal epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (10)

• To further evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs

  12 weeks

• To assess trends over time in efficacy of vormatrogine on focal seizure frequency

  12 weeks

• To assess the safety and tolerability of vormatrigine in adults with focal seizures

  12 weeks

• To assess the safety and tolerability of vormatrigine in adults with focal seizures

  12 weeks

• To assess the safety and tolerability of vormatrigine in adults with focal seizures

  12 weeks

Study Arms (4)

40 mg/day vormatrogine for 12 weeks

EXPERIMENTAL

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

Drug: 40 mg/day vormatrogine for 12 weeks

30 mg/day vormatrogine for 12 weeks

EXPERIMENTAL

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

Drug: 30 mg/day vormatrogine for 12 weeks

20 mg/day vormatrogine for 12 weeks

EXPERIMENTAL

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

Drug: 20 mg/day vormatrogine for 12 weeks

Placebo per day for 12 weeks

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

40 mg/day vormatrogine for 12 weeks DRUG

Once daily oral

40 mg/day vormatrogine for 12 weeks

30 mg/day vormatrogine for 12 weeks DRUG

Once daily oral

30 mg/day vormatrogine for 12 weeks

20 mg/day vormatrogine for 12 weeks DRUG

Once daily oral

20 mg/day vormatrogine for 12 weeks

Placebo DRUG

Once daily oral

Placebo per day for 12 weeks

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a diagnosis of focal onset epilepsy according to the International League Against Epilepsy Classification of Epilepsy (2017).
• Prior to randomization, past evidence by CT or MRI that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
• Participant must attest to be taking stable doses of 1 or up to 3 acceptable ASMs for at least 4 weeks prior to screening and during screening prior to Day 1.
• Has at least 4 countable focal onset seizures during the 4 weeks of Observation Period immediately prior to randomization with no more than 21 days seizure free during this period.
• Seizure diary must be completed for ≥80% days in the Observation Period.

You may not qualify if:

• Participant has had any of the following within the 12-month period preceding trial entry:
• evidence of experiencing pseudo or psychogenic seizures
• cluster seizures where the individual seizures cannot be counted
• an episode of convulsive status epilepticus requiring hospitalization and intubation
• seizures secondary to illicit drug or alcohol use
• Seizures secondary to ongoing infection, neoplasia, demyelinating disease, progressive degenerative disease, metabolic illness deemed progressive, progressive structural lesion or encephalopathy.
• Previously documented EEG which shows any pattern not consistent with focal etiology of seizures.
• Planned epilepsy surgery during the course of the clinical trial.
• History of any of the following:
• neurosurgery for seizures \<1 year prior to enrollment
• radiosurgery \<2 years prior to enrollment
• neurostimulator placed \<1 year prior to Screening
• neurostimulator placed \>1 year prior to Screening but settings have not been stable for at least 2 months prior to Screening
• Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt, as confirmed by C-SSRS.
• Has any significant ongoing disease, disorder, laboratory abnormalities, alcohol or drug abuse or dependence, environmental factor, or ongoing or recent history of any psychiatric, medical, or surgical condition.

Sponsors & Collaborators

• Praxis Precision Medicines: lead

Study Sites (7)

Praxis Research Site

Miami, Florida, 33133, United States

RECRUITING

Praxis Research Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Praxis Research Site

Naples, Florida, 34116, United States

NOT YET RECRUITING

Praxis Research Site

Marlboro, New Jersey, 07746, United States

RECRUITING

Praxis Research Site

Niagara Falls, New York, 14304, United States

RECRUITING

Praxis Research Site

Raleigh, North Carolina, 27607, United States

RECRUITING

Praxis Research Site

Houston, Texas, 77058, United States

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Praxis Precision Medicines

  Praxis Precision Medicines

  STUDY DIRECTOR

Central Study Contacts

Senior Medical Director Clinical Development

CONTACT

773-939-6858; clinicaltrials@praxismedicines.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (7)