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A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
Sponsor: Praxis Precision Medicines
Summary
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
Official title: 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 DEE Followed by an Open-Label Extension
Key Details
Gender
All
Age Range
2 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-07-09
Completion Date
2027-07
Last Updated
2025-12-18
Healthy Volunteers
No
Interventions
1.0mg/kg/day PRAX-562
Once daily orally or gastronomy/jejunostomy
1.5mg/kg/day PRAX-562
Once daily orally or gastronomy/jejunostomy
Placebo
Once daily orally or gastronomy/jejunostomy
Locations (5)
Praxis Research Site
La Jolla, California, United States
Praxis Research Site
Gulf Breeze, Florida, United States
Praxis Research Site
Chevy Chase, Maryland, United States
Praxis Research Site
Roseville, Minnesota, United States
Praxis Research Site
São Paulo, Brazil