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Recruiting NCT06908356

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

Phase II Interventional Focal Onset Seizure Primary Generalized Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 30mg PRAX-628.
Who it may be relevant to
Registry conditions: Focal Onset Seizure, Primary Generalized Epilepsy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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 who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.

Interventions

  • Drug 30mg PRAX-628
    Once daily oral

Primary outcome measures

  • To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [Time frame: 8 weeks]
Secondary outcome measures (6)
  • To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [Time frame: 8 weeks]
  • To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [Time frame: 8 weeks]
  • To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs [Time frame: 8 weeks]
  • CGI-S Change from Baseline [Time frame: 8 weeks]
  • PGI-S Change from Baseline [Time frame: 8 weeks]
  • To assess the safety and tolerability of PRAX-628 in adults with FOS or PGTCS currently taking ASMs [Time frame: 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Praxis Research Site — Phoenix
  • Praxis Research Site — Miami Lakes
  • Praxis Research Site — Bethesda
  • Praxis Research Site — Chesterfield
  • Praxis Research Site — Hackensack
  • Praxis Research Site — Middletown
  • Praxis Research Site — Round Rock
  • Praxis Research Site — Seabrook
Australia · 2 centers
  • Praxis Research Site — Heidelberg
  • Praxis Research Site — Melbourne
Spain · 1 center
  • Praxis Research Site — Madrid

Identifiers

NCT: NCT06908356 · PRAX-628-212

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗