Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)

Praxis Precision Medicines

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Focal Seizure

Treatments: Drug: Placebo; Drug: 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT06999902

PRAX-628-321

Details and patient eligibility

About

A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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230 participants in 2 patient groups

Randomized, Double-Blind 20mg/day for 6 weeks then 30mg/day for remaining 6 weeks PRAX-628

Experimental group

Description:

Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 20 mg of PRAX-628 for 6 weeks followed by 30 mg PRAX 628 for the remaining 6 weeks.

Treatment:

Drug: 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks

Randomized, Double-Blind Placebo

Experimental group

Description:

Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive a matching placebo throughout the 12-week Treatment Period

Treatment:

Drug: Placebo