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Tests treatment safety and results for Focal Onset Seizure
Official title An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
ClinicalTrials.gov ID: NCT06908356
What this study is testing
What is 30mg PRAX-628?
30mg PRAX-628 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for focal onset seizure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
You likely can't join if
- History of pseudo or psychogenic seizures, or cluster seizures only, within the 12-month period preceding study entry where the individual seizures...
- 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.
See the full eligibility 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Miami Lakes, Florida, United States
- Bethesda, Maryland, United States
- Chesterfield, Missouri, United States
- Hackensack, New Jersey, United States
- Middletown, New York, United States
- Round Rock, Texas, United States
- Seabrook, Texas, United States
- Heidelberg, Australia
- Melbourne, Australia
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Miami Lakes, Florida, United States; Bethesda, Maryland, United States; Chesterfield, Missouri, United States; Hackensack, New Jersey, United States; Middletown, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.