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
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• A diagnosis of focal onset seizures or idiopathic generalized tonic clonic seizures.
• Evidence by computed tomography (CT) or magnetic resonance imaging (MRI) in the past that has ruled out a progressive cause of epilepsy.
• Participant must have been receiving stable doses of allowable ASMs (a minimum of 1 and a maximum of 3 ASMs).
• Participant and/or caregiver (if applicable) self-reports at least 2 countable focal onset seizures per month for focal onset patients, or 1 countable generalized tonic-clonic seizure per month in the 3 months immediately prior to the Screening/Observation Period for PGTCS patients.
Locations
United States
Arizona
Praxis Research Site
RECRUITING
Phoenix
Florida
Praxis Research Site
RECRUITING
Miami Lakes
Maryland
Praxis Research Site
RECRUITING
Bethesda
Missouri
Praxis Research Site
RECRUITING
Chesterfield
New Jersey
Praxis Research Site
RECRUITING
Hackensack
New York
Praxis Research Site
RECRUITING
Middletown
Texas
Praxis Research Site
RECRUITING
Round Rock
Praxis Research Site
RECRUITING
Seabrook
Other Locations
Australia
Praxis Research Site
RECRUITING
Heidelberg
Praxis Research Site
RECRUITING
Melbourne
Spain
Praxis Research Site
RECRUITING
Madrid
Contact Information
Primary
Head of Pharmacovigilance
clinicaltrials@praxismedicines.com
617-300-8460
Time Frame
Start Date:2025-01-10
Estimated Completion Date:2025-07
Participants
Target number of participants:50
Treatments
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.