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

ClinicalTrials.gov ID: NCT07010471

Public ClinicalTrials.gov record NCT07010471. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 18, 2026, 4:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID: NCT07010471
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Praxis Precision Medicines; Industry
Enrollment: 160 participants

Conditions and interventions

Conditions

Developmental and Epileptic Encephalopathy 1

Interventions

1.0mg/kg/day PRAX-562 Drug
1.5mg/kg/day PRAX-562 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 2 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 8, 2025
Primary completion: Nov 30, 2026
Completion: Oct 31, 2027
Last update posted: May 10, 2026

2025 – 2027

United States locations

U.S. sites: 6
U.S. states: 6
U.S. cities: 6

Facility	City	State	ZIP	Site status
Praxis Research Site	La Jolla	California	92037	Recruiting
Praxis Research Site	Gulf Breeze	Florida	32561	Recruiting
Praxis Research Site	Chevy Chase	Maryland	20815	Recruiting
Praxis Research Site	Roseville	Minnesota	55113	Recruiting
Praxis Research Site	Hackensack	New Jersey	07601	Recruiting
Praxis Research Site	Philadelphia	Pennsylvania	19104	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07010471, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 10, 2026 · Synced May 18, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07010471 live on ClinicalTrials.gov.

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