NCT06999902 Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)
| NCT ID | NCT06999902 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Praxis Precision Medicines |
| Condition | Focal Seizure |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2024-12-11 |
| Primary Completion | 2025-11-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 230 participants in total. It began in 2024-12-11 with a primary completion date of 2025-11-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Praxis Precision Medicines
Frequently Asked Questions
Who can join the NCT06999902 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Focal Seizure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06999902 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06999902 currently recruiting?
Yes, NCT06999902 is actively recruiting participants. Contact the research team at clinicaltrials@praxismedicines.com for enrollment information.
Where is the NCT06999902 trial being conducted?
This trial is being conducted at Phoenix, United States, DeLand, United States, Miami Lakes, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT06999902 clinical trial?
NCT06999902 is sponsored by Praxis Precision Medicines. The principal investigator is Medical Director at Praxis Precision Medicines. The trial plans to enroll 230 participants.