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Tests treatment safety and results for Developmental and Epileptic Encephalopathy 1
Official title A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
ClinicalTrials.gov ID: NCT07010471
What this study is testing
What is 1.0mg/kg/day PRAX-562?
1.0mg/kg/day PRAX-562 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for developmental and epileptic encephalopathy 1.
Also referred to as relutrigine.
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
- A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Relutrigine in Participants with Developmental and Epileptic Encephalopathies Followed by an Open-Label Extension
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 65
You may be able to join if
- Has a documented diagnosis of a developmental and epileptic encephalopathy.
- Onset of seizures \<12 years old.
- Has a weight \>7 kg at the time of signing consent/assent.
You likely can't join if
- Has a history of left bundle branch block, arrhythmias, Brugada syndrome, congenital heart disease, familial short QT syndrome, or family history of...
- Had 2 or more episodes of convulsive status epilepticus requiring hospitalization and intubation in the 6 months prior to Screening.
- Has an abnormal ECG reading, including a QT interval corrected for heart rate using Bazett's method (QTcB) \ 450 ms (males), or \ 460 ms (females) at...
- Any nerve stimulation must have been placed at least 3 months prior to Screening with at least 1 month of stable settings prior to Screening.
- Has received any other experimental or investigational drug, device, or other therapy within 30 days or 5 half-lives (whichever is longer) prior to...
- Is currently pregnant or breastfeeding or is planning to become pregnant during the clinical trial or within 5 half-lives of the last study drug dose.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Gulf Breeze, Florida, United States
- Chevy Chase, Maryland, United States
- Roseville, Minnesota, United States
- Hackensack, New Jersey, United States
- Philadelphia, Pennsylvania, United States
- Heidelberg, Victoria, Australia
- Rio Grande, Do Sul, Brazil
- Paraná, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
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, 2 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Gulf Breeze, Florida, United States; Chevy Chase, Maryland, United States; Roseville, Minnesota, United States; Hackensack, New Jersey, United States; Philadelphia, Pennsylvania, 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.