Actively Recruiting
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
Led by Praxis Precision Medicines · Updated on 2025-04-03
50
Participants Needed
11
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Imaging evidence from CT or MRI ruling out progressive causes of epilepsy
- Stable doses of 1 to 3 acceptable anti-seizure medications
- At least 2 countable focal onset seizures per month (for focal onset patients) or 1 countable generalized tonic-clonic seizure per month in the past 3 months (for PGTCS patients)
You will not qualify if you...
- History of pseudo, psychogenic, or cluster seizures only in 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 less than 1 year prior to enrollment or radiosurgery less than 2 years prior
- Schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders
- Active suicidal plan or intent in past 6 months, or suicide attempt in last 2 years, or more than one lifetime attempt
- History of malignancy, myeloproliferative or lymphoproliferative disorders in past 5 years
- History of cardiac disease, conduction disorders, or structural abnormalities
- Pregnant, breastfeeding, positive pregnancy test, or planning pregnancy during or within 14 days after study drug
- Use of experimental drug, device, or therapy within 30 days or 5 half-lives prior to screening, or any prior gene therapy
- Use of vigabatrin in last 5 years without stable visual field tests twice over 12 months after last dose
- Use of felbamate less than 2 years or unstable dose within 2 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
3
Praxis Research Site
Bethesda, Maryland, United States, 20817
Actively Recruiting
4
Praxis Research Site
Chesterfield, Missouri, United States, 63005
Actively Recruiting
5
Praxis Research Site
Hackensack, New Jersey, United States, 07601
Actively Recruiting
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here