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
Praxis Precision Medicines
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
Description
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 who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Scre…
Interventions
- Drug30mg PRAX-628
Once daily oral
Locations (11)
- Praxis Research SitePhoenix, Arizona
- Praxis Research SiteMiami Lakes, Florida
- Praxis Research SiteBethesda, Maryland
- Praxis Research SiteChesterfield, Missouri
- Praxis Research SiteHackensack, New Jersey
- Praxis Research SiteMiddletown, New York