Status:
RECRUITING
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
Lead Sponsor:
Praxis Precision Medicines
Conditions:
Focal Onset Seizure
Primary Generalized Epilepsy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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
Detailed 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 le...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of pseudo or psychogenic seizures, or cluster seizures only, within the 12-month period preceding study entry where the individual seizures cannot be counted, or an episode of convulsive status epilepticus requiring hospitalization and intubation in the 12 months prior to Screening.
- Planned epilepsy surgery during the course of the clinical trial.
- History of neurosurgery for seizures \<1 year prior to enrollment, or radiosurgery \<2 years prior to enrollment.
- Schizophrenia and obsessive-compulsive disorder, or other serious mental health disorders.
- Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
- Participants with a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded.
- History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies).
- Is pregnant or breastfeeding at the time of Screening, or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or within 14 days of the last study drug dose.
- Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene therapy.
- Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin.
- Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to Screening.
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06908356
Start Date
January 10 2025
End Date
July 1 2025
Last Update
April 3 2025
Active Locations (11)
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1
Praxis Research Site
Phoenix, Arizona, United States, 85032
2
Praxis Research Site
Miami Lakes, Florida, United States, 30116
3
Praxis Research Site
Bethesda, Maryland, United States, 20817
4
Praxis Research Site
Chesterfield, Missouri, United States, 63005