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RECRUITING
NCT07010471
PHASE3

A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine

Sponsor: Praxis Precision Medicines

View on ClinicalTrials.gov

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

DRUG

1.0mg/kg/day PRAX-562

Once daily orally or gastronomy/jejunostomy

DRUG

1.5mg/kg/day PRAX-562

Once daily orally or gastronomy/jejunostomy

DRUG

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