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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
Led by Praxis Precision Medicines · Updated on 2025-04-03
50
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the efficacy and safety of PRAX-628 in adults with focal onset seizures or primary generalized tonic-clonic seizures who are currently taking between one and three anti-seizure medications. The study is an open label clinical trial designed to assess how well PRAX-628 controls seizure frequency and its tolerability in this population. Participants who qualify will receive 30 mg of PRAX-628 orally once daily for a period of 8 weeks. This single treatment group will allow researchers to observe the effects of PRAX-628 without a placebo or comparison group. The study focuses on adults aged 18 to 75 years and excludes those with certain medical histories or conditions that might interfere with the trial. During the 8-week treatment, participants will be monitored for seizure frequency and changes in clinical global impressions of severity as well as patient global impressions. Safety and tolerability will be carefully tracked throughout the study. The main outcome is the change in seizure frequency, with additional assessments of symptom severity and side effects. Participation involves regular visits and evaluations to ensure thorough monitoring of responses to PRAX-628.
CONDITIONS
Brief Title
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of focal onset seizures or idiopathic generalized tonic-clonic seizures
- Previous imaging (CT or MRI) ruling out a progressive cause of epilepsy
- Stable doses of 1 to 3 acceptable anti-seizure medications
- Self-reported at least 2 focal onset seizures per month or 1 generalized tonic-clonic seizure per month in the past 3 months
You will not qualify if you...
- History of pseudo or psychogenic seizures or cluster seizures within the past 12 months
- Convulsive status epilepticus requiring hospitalization and intubation in the past 12 months
- Planned epilepsy surgery during the trial
- Neurosurgery for seizures within 1 year or radiosurgery within 2 years before enrollment
- Serious mental health disorders including schizophrenia or obsessive-compulsive disorder
- Active suicidal plan or intent in past 6 months, or suicide attempts in past 2 years
- History of malignancy or blood disorders within 5 years
- History of cardiac disease or conduction disorders
- Pregnant, breastfeeding, or planning pregnancy during study or within 14 days after last dose
- Use of other experimental treatments within 30 days prior or prior gene therapy
- Recent or unstable use of vigabatrin or felbamate as specified in protocol criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants take 30mg of PRAX-628 once daily to evaluate efficacy and safety in adults with focal onset or primary generalized tonic-clonic seizures.
Trial Site Locations
Total: 11 locations
1
Praxis Research Site
Phoenix, Arizona, United States, 85032
Actively Recruiting
2
Praxis Research Site
Miami Lakes, Florida, United States, 30116
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3
Praxis Research Site
Bethesda, Maryland, United States, 20817
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4
Praxis Research Site
Chesterfield, Missouri, United States, 63005
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5
Praxis Research Site
Hackensack, New Jersey, United States, 07601
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6
Praxis Research Site
Middletown, New York, United States, 10941
Actively Recruiting
7
Praxis Research Site
Round Rock, Texas, United States, 78681
Actively Recruiting
8
Praxis Research Site
Seabrook, Texas, United States, 77586
Actively Recruiting
9
Praxis Research Site
Heidelberg, Australia, 03084
Actively Recruiting
10
Praxis Research Site
Melbourne, Australia, 03004
Actively Recruiting
11
Praxis Research Site
Madrid, Spain, 28010
Actively Recruiting
Research Team
H
Head of Pharmacovigilance
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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