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PRAX-562 for Epilepsy (EMBOLD Trial)
EMBOLD Trial Summary
This trial will explore if a new medicine is safe, tolerated and effective for children with early-onset seizures.
EMBOLD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMBOLD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EMBOLD Trial Design
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Who is running the clinical trial?
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- I have a genetic variant linked to my epilepsy or developmental disorder, not related to SCN2A or SCN8A genes.I've been hospitalized and intubated for seizures at least twice in the last 6 months.My genetic test shows a specific mutation that worsened my seizures after taking certain seizure medications.I've had at least 8 motor seizures in the last 4 weeks and during a 28-day observation period.I have a rare SCN2A variant with seizures starting in the first 3 months, or a new SCN8A variant with seizures in the first 6 months.
- Group 1: Part A: Randomized, Double-Blind 0.5mg/kg/day PRAX-562 or PRAX-562/Placebo
- Group 2: Part B: Open-Label Extension Treatment 0.5mg/kg/day PRAX-562
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How perilous is the 0.5mg/kg/day PRAX-562 dosage during Part B: Open-Label Extension Treatment?
"Taking into account the Phase 2 nature of this study, there is evidence to suggest that Part B: Open-Label Extension Treatment 0.5mg/kg/day PRAX-562 is moderately safe and thus has been rated a score of two by our team at Power."
Are there any opportunities for the public to partake in this clinical experiment?
"Affirmative, clinicaltrials.gov holds evidence that this medical study began enrolling patients on April 17th 2023 and was recently updated a day later. At present, there is need for up to 20 volunteers at one site."
Is participation in this research project restricted to persons below a certain age?
"This medical trial is designed for children and adolescents between 2-18 years old. According to the data on clinicaltrials.gov, there are 162 trials available for those younger than 18 and 231 studies catering towards seniors aged 65 or older."
What is the scale of this experimental treatment?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting individuals; it was initially listed on April 17th 2023 and most recently updated on the 18th of the same month. This study aims to enrol a total of twenty participants from one site."
Who meets the qualifications to take part in this experimentation?
"For this research endeavour, 20 minors between the ages of 2 and 18 that are currently afflicted with encephalopathy must be recruited. To qualify for enrolment in the study, participants ought to possess at least eight motor seizures (as outlined by the accompanying note) within four weeks before screening according to a parent/guardian or investigator's account. Furthermore, additional inclusion criteria will be evaluated by the clinical team."
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