Recruiting NCT06999902
Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks, Placebo.
- Who it may be relevant to
- Registry conditions: Focal Seizure. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
Overview
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.
Interventions
- Drug 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
Once daily oral - Drug Placebo
Once daily oral
Primary outcome measures
- To evaluate the efficacy of PRAX-628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs [Time frame: 12 weeks]
Secondary outcome measures (11)
- To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs [Time frame: 12 weeks]
- To assess trends over time in efficacy of PRAX 628 on focal seizure frequency [Time frame: 12 weeks]
- To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs [Time frame: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Time frame: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Time frame: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Time frame: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Time frame: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Time frame: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Time frame: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Time frame: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- Praxis Research Site — Phoenix
- Praxis Research Site — DeLand
- Praxis Research Site — Miami Lakes
- Praxis Research Site — Chicago
- Praxis Research Site — Lafayette
- Praxis Research Site — Bethesda
- Praxis Research Site — Chesterfield
- Praxis Research Site — Ozark
- … and 8 more centers
Spain · 10 centers
- Praxis Research Site — Barcelona
- Praxis Research Site — Barcelona
- Praxis Research Site — Barcelona
- Praxis Research Site — Granda
- Praxis Research Site — Madrid
- Praxis Research Site — Madrid
- Praxis Research Site — Madrid
- Praxis Research Site — Málaga
- … and 2 more centers
Identifiers
NCT: NCT06999902 · PRAX-628-321