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

Part of paid clinical trials in Miami, Florida.

Sponsor
Praxis Precision Medicines
Study ID
NCT07505004
Phase
PHASE3
Status
Recruiting
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Conditions

  • Focal Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 40 mg/day vormatrogine for 12 weeks — DRUG
    Once daily oral
  • 30 mg/day vormatrogine for 12 weeks — DRUG
    Once daily oral
  • 20 mg/day vormatrogine for 12 weeks — DRUG
    Once daily oral
  • Placebo — DRUG
    Once daily oral

Study Details

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

Key Dates

Start date
Jan 29, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 40 mg/day vormatrogine for 12 weeks
    Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 40 mg of vormatrogine
  • Experimental: 30 mg/day vormatrogine for 12 weeks
    Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 30 mg of vormatrogine
  • Experimental: 20 mg/day vormatrogine for 12 weeks
    Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 20 mg of vormatrogine
  • Placebo Comparator: Placebo per day for 12 weeks
    Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive placebo

Primary Outcome Measure

To evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs [ Time Frame: 12 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Praxis Research SiteMiamiFlorida33133-
Praxis Research SiteMiami LakesFlorida33016-
Praxis Research SiteNaplesFlorida34116-
Praxis Research SiteMarlboroNew Jersey07746-
Praxis Research SiteNiagara FallsNew York14304-
Praxis Research SiteRaleighNorth Carolina27607-
Praxis Research SiteHoustonTexas77058-

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By research site
Praxis Research Site· Miami, FLPraxis Research Site· Miami Lakes, FLPraxis Research Site· Naples, FLPraxis Research Site· Marlboro, NJPraxis Research Site· Niagara Falls, NYPraxis Research Site· Raleigh, NC

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