An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures

NCT06908356 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PRAX-628-212
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 11

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

Keywords

Focal Onset Seizure; Primary Generalized Epilepsy; Tonic-Clonic

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs

  Median percent change in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628

  8 weeks

Secondary Outcomes (6)

• To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs

  8 weeks

• To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs

  8 weeks

• To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs

  8 weeks

• CGI-S Change from Baseline

  8 weeks

• PGI-S Change from Baseline

  8 weeks

Study Arms (1)

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

EXPERIMENTAL

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

Drug: 30mg PRAX-628

Interventions

30mg PRAX-628 DRUG

Once daily oral

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Praxis Precision Medicines: lead

Study Sites (11)

Praxis Research Site

Phoenix, Arizona, 85032, United States

RECRUITING

Praxis Research Site

Miami Lakes, Florida, 30116, United States

RECRUITING

Praxis Research Site

Bethesda, Maryland, 20817, United States

RECRUITING

Praxis Research Site

Chesterfield, Missouri, 63005, United States

RECRUITING

Praxis Research Site

Hackensack, New Jersey, 07601, United States

RECRUITING

Praxis Research Site

Middletown, New York, 10941, United States

RECRUITING

Praxis Research Site

Round Rock, Texas, 78681, United States

RECRUITING

Praxis Research Site

Seabrook, Texas, 77586, United States

RECRUITING

Praxis Research Site

Heidelberg, 03084, Australia

RECRUITING

Praxis Research Site

Melbourne, 03004, Australia

RECRUITING

Praxis Research Site

Madrid, 28010, Spain

RECRUITING

MeSH Terms

Conditions

Seizures; Epilepsy, Idiopathic Generalized

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Praxis Precision Medicines

  STUDY DIRECTOR

Central Study Contacts

Head of Pharmacovigilance

CONTACT

617-300-8460; clinicaltrials@praxismedicines.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 3, 2025
• Study Start: January 10, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

ES (1); AU (2); US (8)