Clinical trial NCT06999902: Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)
Official title: A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Focal Seizure
Keywords: Focal Seizure
Lead sponsor: Praxis Precision Medicines
Sponsor class: INDUSTRY
First posted: 2025-05-31
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 acceptable anti-seizure medications.

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy.
2. 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 Criteria:

1. 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.
2. Planned epilepsy surgery during the course of the clinical trial.
3. History of neurosurgery for seizures \<1 year prior to enrollment, or radiosurgery \<2 years prior to enrollment or vagus nerve stimulation (VNS) implantation.
4. History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders.
5. History of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded.
6. History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies).
7. 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.
8. 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.
9. 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.

Primary outcomes:
measure: To evaluate the efficacy of PRAX-628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
timeFrame: 12 weeks
Secondary outcomes:
measure: To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
timeFrame: 12 weeks
measure: To assess trends over time in efficacy of PRAX 628 on focal seizure frequency
timeFrame: 12 weeks
measure: To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
timeFrame: 12 weeks
measure: To assess the safety and tolerability of PRAX-628 in adults with focal seizures
timeFrame: 12 weeks
measure: To assess the safety and tolerability of PRAX-628 in adults with focal seizures
timeFrame: 12 weeks
measure: To assess the safety and tolerability of PRAX-628 in adults with focal seizures
timeFrame: 12 weeks
measure: To assess the safety and tolerability of PRAX-628 in adults with focal seizures
timeFrame: 12 weeks
measure: To assess the safety and tolerability of PRAX-628 in adults with focal seizures
timeFrame: 12 weeks
measure: To assess the safety and tolerability of PRAX-628 in adults with focal seizures
timeFrame: 12 weeks
measure: To assess the safety and tolerability of PRAX-628 in adults with focal seizures
timeFrame: 12 weeks
measure: To assess the safety and tolerability of PRAX-628 in adults with focal seizures
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Praxis Research Site
state: Arizona
city: DeLand
country: United States
facility: Praxis Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Praxis Research Site
state: Florida
city: Chicago
country: United States
facility: Praxis Research Site
state: Illinois
city: Lafayette
country: United States
facility: Praxis Research Site
state: Louisiana
city: Bethesda
country: United States
facility: Praxis Research Site
state: Maryland
city: Chesterfield
country: United States
facility: Praxis Research Site
state: Missouri
city: Ozark
country: United States
facility: Praxis Research Site
state: Missouri
city: Hackensack
country: United States
facility: Praxis Research Site
state: New Jersey
city: Middletown
country: United States
facility: Praxis Research Site
state: New York
city: Canton
country: United States
facility: Praxis Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Praxis Research Site
state: Oklahoma
city: El Paso
country: United States
facility: Praxis Research Site
state: Texas
city: Frisco
country: United States
facility: Praxis Research Site
state: Texas
city: Round Rock
country: United States
facility: Praxis Research Site
state: Texas
city: Seabrook
country: United States
facility: Praxis Research Site
state: Texas
city: Barcelona
country: Spain
facility: Praxis Research Site
city: Barcelona
country: Spain
facility: Praxis Research Site
city: Barcelona
country: Spain
facility: Praxis Research Site
city: Granda
country: Spain
facility: Praxis Research Site
city: Madrid
country: Spain
facility: Praxis Research Site
city: Madrid
country: Spain
facility: Praxis Research Site
city: Madrid
country: Spain
facility: Praxis Research Site
city: Málaga
country: Spain
facility: Praxis Research Site
city: Terrassa
country: Spain
facility: Praxis Research Site
city: Valencia
country: Spain
facility: Praxis Research Site
Study officials:
affiliation: Praxis Precision Medicines
name: Medical Director
role: STUDY_DIRECTOR
References: