NCT06908356 An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
| NCT ID | NCT06908356 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Praxis Precision Medicines |
| Condition | Focal Onset Seizure |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2025-07 |
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 50 participants in total. It began in 2025-01-10 with a primary completion date of 2025-07.
⚠ 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
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures
Eligibility Criteria
Inclusion Criteria: * A diagnosis of focal onset seizures or idiopathic generalized tonic clonic seizures. * Evidence by computed tomography (CT) or magnetic resonance imaging (MRI) in the past that has ruled out a progressive cause of epilepsy. * Participant must have been receiving stable doses of allowable ASMs (a minimum of 1 and a maximum of 3 ASMs). * Participant and/or caregiver (if applicable) self-reports at least 2 countable focal onset seizures per month for focal onset patients, or 1 countable generalized tonic-clonic seizure per month in the 3 months immediately prior to the Screening/Observation Period for PGTCS patients. Exclusion Criteria: * History of pseudo or psychogenic seizures, or cluster seizures only, within the 12-month period preceding study entry where the individual seizures cannot be counted, or an episode of convulsive status epilepticus requiring hospitalization and intubation in the 12 months prior to Screening. * 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. * Schizophrenia and obsessive-compulsive disorder, or other serious mental health disorders. * Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt. * Participants with a 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). * Is pregnant or 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. * Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin. * Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to Screening.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Praxis Precision Medicines
Frequently Asked Questions
Who can join the NCT06908356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Focal Onset 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 NCT06908356 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 NCT06908356 currently recruiting?
Yes, NCT06908356 is actively recruiting participants. Contact the research team at clinicaltrials@praxismedicines.com for enrollment information.
Where is the NCT06908356 trial being conducted?
This trial is being conducted at Phoenix, United States, Miami Lakes, United States, Bethesda, United States, Chesterfield, United States and 7 additional locations.
Who is sponsoring the NCT06908356 clinical trial?
NCT06908356 is sponsored by Praxis Precision Medicines. The principal investigator is Medical Director at Praxis Precision Medicines. The trial plans to enroll 50 participants.