RECRUITING

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

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Conditions

Developmental and Epileptic Encephalopathy 1DEEDevelopmental and Epileptic Encephalopathyepilepsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-07-09
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07010471

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has a documented diagnosis of a developmental and epileptic encephalopathy.
  2. * Onset of seizures \<12 years old.
  3. * Has a weight \>7 kg at the time of signing consent/assent.
  1. * 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.
  2. * Had 2 or more episodes of convulsive status epilepticus requiring hospitalization and intubation in the 6 months prior to Screening.
  3. * 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.
  4. * 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.
  5. * 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.
  6. * 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.

Contacts and Locations

Study Contact

Head of Pharmacovigilance
CONTACT
617-300-8460
clinicaltrials@praxismedicines.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Praxis Precision Medicines

Study Locations (Sites)

Praxis Research Site
Chevy Chase, Maryland, 20815
United States

Collaborators and Investigators

Sponsor: Praxis Precision Medicines

  • Medical Director, STUDY_DIRECTOR, Praxis Precision Medicines

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-09
Study Completion Date2027-02

Study Record Updates

Study Start Date2025-07-09
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • DEE
  • Developmental and Epileptic Encephalopathy
  • epilepsy

Additional Relevant MeSH Terms

  • Developmental and Epileptic Encephalopathy 1