Recruiting
Phase 2

PRAX-628

Sponsor:

Praxis Precision Medicines

Code:

NCT06908356

Conditions

Focal Onset Seizure

Primary Generalized Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

30mg PRAX-628

Study Details

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

Conditions

Focal Onset Seizure

Primary Generalized Epilepsy

Study ID

NCT06908356

Start date

Jan 10, 2025

Status verified date

Mar, 2025

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-label 30mg/day PRAX-628 for 8 weeks

Participants who meet all eligibility criteria will receive 30mg of PRAX-628 for 8 weeks.

Interventions

30mg PRAX-628

Once daily oral

Primary outcome measure

  • To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Head of Pharmacovigilance

617-300-8460clinicaltrials@praxismedicines.com

Locations

Praxis Research Site

Recruiting

Phoenix, Arizona, United States, 85032

Praxis Research Site

Recruiting

Miami Lakes, Florida, United States, 30116

Praxis Research Site

Recruiting

Bethesda, Maryland, United States, 20817

Praxis Research Site

Recruiting

Chesterfield, Missouri, United States, 63005

Praxis Research Site

Recruiting

Hackensack, New Jersey, United States, 07601

Praxis Research Site

Recruiting

Middletown, New York, United States, 10941

Praxis Research Site

Recruiting

Round Rock, Texas, United States, 78681

Praxis Research Site

Recruiting

Seabrook, Texas, United States, 77586

More Information

Sponsor

Praxis Precision Medicines

Last update posted

Apr 3, 2025

Last verified

Mar, 2025

Keywords

  • Focal Onset Seizure
  • Primary Generalized Epilepsy
  • Tonic-Clonic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Praxis Precision Medicines on 2025-04-03.