Focal Seizure
Conditions
Keywords
Focal Seizure
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.
Interventions
DRUG20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
Once daily oral
DRUGPlacebo
Once daily oral
Sponsors
Praxis Precision Medicines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of PRAX-628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs | 12 weeks | Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs | 12 weeks | Proportion of participants experiencing a ≥50% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX 628 compared to placebo. |
| To assess trends over time in efficacy of PRAX 628 on focal seizure frequency | 12 weeks | Percent change in monthly focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared with placebo. |
| To assess the safety and tolerability of PRAX-628 in adults with focal seizures | 12 weeks | Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs |
Countries
Brazil, Canada, Italy, Mexico, Poland, Spain, United States
Contacts
STUDY_DIRECTORMedical Director
Praxis Precision Medicines
Outcome results
None listed