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
Sex
ALL
Min age
18 Years
Max age
75 Years
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 Screening/Observation Period for PGTCS patients.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs — 8 weeks Median percent change in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628
Trial sites (11)
Facility
City
Region
Status
Praxis Research Site
Phoenix
Arizona
Recruiting
Praxis Research Site
Miami Lakes
Florida
Recruiting
Praxis Research Site
Bethesda
Maryland
Recruiting
Praxis Research Site
Chesterfield
Missouri
Recruiting
Praxis Research Site
Hackensack
New Jersey
Recruiting
Praxis Research Site
Middletown
New York
Recruiting
Praxis Research Site
Round Rock
Texas
Recruiting
Praxis Research Site
Seabrook
Texas
Recruiting
Praxis Research Site
Heidelberg
Australia
Recruiting
Praxis Research Site
Melbourne
Australia
Recruiting
Praxis Research Site
Madrid
Spain
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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