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

Recruiting Phase 3 Interventional Study
Developmental and Epileptic Encephalopathy 1
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
Praxis Precision Medicines · Industry
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About This Trial

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

Trial Locations
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Eligibility Criteria
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, congen…
Contacts

Head of Pharmacovigilance

617-300-8460

clinicaltrials@praxismedicines.com

CONTACT