An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Praxis Precision Medicines
Study ID
NCT06908356
Phase
PHASE2
Status
Recruiting
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Conditions

  • Focal Onset Seizure
  • Primary Generalized Epilepsy

Eligibility Criteria

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

Interventions

  • 30mg PRAX-628 — DRUG
    Once daily oral

Study Details

An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures

Key Dates

Start date
Jan 10, 2025
Status verified
Mar 2025
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label 30mg/day PRAX-628 for 8 weeks
    Participants who meet all eligibility criteria will receive 30mg of PRAX-628 for 8 weeks.

Primary Outcome Measure

To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [ Time Frame: 8 weeks ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Praxis Research SitePhoenixArizona85032-
Praxis Research SiteMiami LakesFlorida30116-
Praxis Research SiteBethesdaMaryland20817-
Praxis Research SiteChesterfieldMissouri63005-
Praxis Research SiteHackensackNew Jersey07601-
Praxis Research SiteMiddletownNew York10941-
Praxis Research SiteRound RockTexas78681-
Praxis Research SiteSeabrookTexas77586-

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Praxis Research Site· Phoenix, AZPraxis Research Site· Miami Lakes, FLPraxis Research Site· Bethesda, MDPraxis Research Site· Chesterfield, MOPraxis Research Site· Hackensack, NJPraxis Research Site· Middletown, NY

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