Status:
RECRUITING
Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)
Lead Sponsor:
Praxis Precision Medicines
Conditions:
Focal Seizure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
Detailed Description
PRAX-628-321 (POWER1) is a double-blind, randomized, multicenter, trial to evaluate the efficacy and safety of PRAX-628 in adults who can attest to concurrently taking at least 1, but no more than 3 a...
Eligibility Criteria
Inclusion
- A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy.
- Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
Exclusion
- Subject has had any of the of the following within the 12-month period preceding trial entry: History of pseudo or psychogenic seizures, cluster seizures where the individual seizures cannot be counted, an episode of convulsive status epilepticus requiring hospitalization and intubation, or subject only has focal seizures with awareness that do not have motor activity.
- 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 or vagus nerve stimulation (VNS) implantation.
- History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders.
- 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).
- Has a positive test result or a known history of a positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody at Screening.
- Is pregnant or is 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.
Key Trial Info
Start Date :
December 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06999902
Start Date
December 11 2024
End Date
December 8 2025
Last Update
May 31 2025
Active Locations (26)
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1
Praxis Research Site
Phoenix, Arizona, United States, 85032
2
Praxis Research Site
DeLand, Florida, United States, 32720
3
Praxis Research Site
Miami Lakes, Florida, United States, 33016
4
Praxis Research Site
Chicago, Illinois, United States, 60640