Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Praxis Precision Medicines
Study ID
NCT06999902
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Focal Seizure

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks — DRUG
    Once daily oral
  • Placebo — DRUG
    Once daily oral

Study Details

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

Key Dates

Start date
Dec 11, 2024
Status verified
May 2025
Primary completion
Nov 24, 2025
Completion
Dec 8, 2025

Study Design

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

Arms

  • Experimental: Randomized, Double-Blind 20mg/day for 6 weeks then 30mg/day for remaining 6 weeks PRAX-628
    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.
  • Experimental: Randomized, Double-Blind Placebo
    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

Primary Outcome Measure

To evaluate the efficacy of PRAX-628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs [ Time Frame: 12 weeks ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Praxis Research SitePhoenixArizona85032-
Praxis Research SiteDeLandFlorida32720-
Praxis Research SiteMiami LakesFlorida33016-
Praxis Research SiteChicagoIllinois60640-
Praxis Research SiteLafayetteLouisiana70508-
Praxis Research SiteBethesdaMaryland20817-
Praxis Research SiteChesterfieldMissouri63005-
Praxis Research SiteOzarkMissouri65721-
Praxis Research SiteHackensackNew Jersey07601-
Praxis Research SiteMiddletownNew York10940-
Praxis Research SiteCantonOhio44718-
Praxis Research SiteOklahoma CityOklahoma73112-
Praxis Research SiteEl PasoTexas79912-
Praxis Research SiteFriscoTexas75034-
Praxis Research SiteRound RockTexas78681-
Praxis Research SiteSeabrookTexas77586-

Find similar trials in Phoenix, AZ

By research site
Praxis Research Site· Phoenix, AZPraxis Research Site· DeLand, FLPraxis Research Site· Miami Lakes, FLPraxis Research Site· Chicago, ILPraxis Research Site· Lafayette, LAPraxis Research Site· Bethesda, MD

Related Studies