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

NCT ID: NCT07010471

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-09

Study Completion Date

2027-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Developmental and Epileptic Encephalopathy 1

Keywords

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DEE Developmental and Epileptic Encephalopathy epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Double-Blind Treatment Period

Eligible participants will be randomly assigned in a double-blind manner and a 1:1 ratio to receive 1.0mg-1.5mg/kg relutrigine or placebo once daily orally or gastronomy/jejunostomy for 16 weeks

Group Type EXPERIMENTAL

1.0mg/kg/day PRAX-562

Intervention Type DRUG

Once daily orally or gastronomy/jejunostomy

1.5mg/kg/day PRAX-562

Intervention Type DRUG

Once daily orally or gastronomy/jejunostomy

Part A: Double-Blind Treatment Period (Placebo)

Eligible participants will be randomly assigned in a double-blind manner and a 1:1 ratio to receive 1.0mg-1.5mg/kg relutrigine or placebo once daily orally or gastronomy/jejunostomy for 16 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily orally or gastronomy/jejunostomy

Part B: Open-Label Extension Treatment Period

Participants from Part A will have the option to rollover to Part B to receive 1.0mg-1.5mg/kg of relutrigine once daily orally or gastronomy/jejunostomy for 32 weeks

Group Type EXPERIMENTAL

1.0mg/kg/day PRAX-562

Intervention Type DRUG

Once daily orally or gastronomy/jejunostomy

1.5mg/kg/day PRAX-562

Intervention Type DRUG

Once daily orally or gastronomy/jejunostomy

Interventions

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1.0mg/kg/day PRAX-562

Once daily orally or gastronomy/jejunostomy

Intervention Type DRUG

1.5mg/kg/day PRAX-562

Once daily orally or gastronomy/jejunostomy

Intervention Type DRUG

Placebo

Once daily orally or gastronomy/jejunostomy

Intervention Type DRUG

Other Intervention Names

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relutrigine

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Has a 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.
* Has an abnormal ECG reading, including a QT interval corrected for heart rate using Bazett's method (QTcB) \<350 and \>450 ms (males), or \<360 and \>460 ms (females) at Screening and/or on Day 1.
* 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 Screening, including any prior use of gene therapy.
* 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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Praxis Precision Medicines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Praxis Precision Medicines

Locations

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Praxis Research Site

La Jolla, California, United States

Site Status RECRUITING

Praxis Research Site

Gulf Breeze, Florida, United States

Site Status RECRUITING

Praxis Research Site

Chevy Chase, Maryland, United States

Site Status RECRUITING

Praxis Research Site

Roseville, Minnesota, United States

Site Status RECRUITING

Praxis Research Site

São Paulo, , Brazil

Site Status RECRUITING

Countries

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United States Brazil

Central Contacts

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Head of Pharmacovigilance

Role: CONTACT

Phone: 617-300-8460

Email: [email protected]

Other Identifiers

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PRAX-562-311

Identifier Type: -

Identifier Source: org_study_id