Actively Recruiting
A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
Led by Praxis Precision Medicines · Updated on 2026-05-11
160
Participants Needed
11
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a documented diagnosis of a developmental and epileptic encephalopathy
- Onset of seizures before 12 years old
- Has a weight greater than 7 kg at the time of signing consent/assent
You will not qualify if you...
- History of left bundle branch block, arrhythmias, Brugada syndrome, congenital heart disease, familial short QT syndrome, or family history of sudden death or ventricular arrhythmias including idiopathic ventricular fibrillation
- Had 2 or more episodes of convulsive status epilepticus requiring hospitalization and intubation in the 6 months prior to Screening
- Abnormal ECG reading including QTcB <350 or >450 ms (males), or <360 or >460 ms (females) at Screening and/or on Day 1
- Any nerve stimulation device placed less than 3 months before Screening or with unstable settings
- Received any experimental or investigational drug, device, or therapy within 30 days or 5 half-lives prior to Screening including gene therapy
- Currently pregnant, breastfeeding, or planning pregnancy during the trial or within 5 half-lives of the last study drug dose
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
La Jolla, California, United States, 92037
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2
Praxis Research Site
Gulf Breeze, Florida, United States, 32561
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3
Praxis Research Site
Chevy Chase, Maryland, United States, 20815
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4
Praxis Research Site
Roseville, Minnesota, United States, 55113
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5
Praxis Research Site
Hackensack, New Jersey, United States, 07601
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6
Praxis Research Site
Philadelphia, Pennsylvania, United States, 19104
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7
Praxis Research Site
Heidelberg, Victoria, Australia, 3084
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8
Praxis Research Site
Rio Grande, Do Sul, Brazil, 90610
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9
Praxis Research Site
Paraná, Brazil, 80250
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10
Praxis Research Site
Rio de Janeiro, Brazil, 20231
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11
Praxis Research Site
São Paulo, Brazil, 15090
Actively Recruiting
Research Team
H
Head of Pharmacovigilance
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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