drugset / Trial / NCT04624750

Open Label Study in Adolescents and Children With Myotonic Disorders

NCT04624750

Phase 3 Completed 12 enrolled Lupin Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, multi-centre, single arm, interventional study to describe the steady-state PK, safety, and efficacy of mexiletine in paediatric patients (6 to \<18 years of age) with myotonic disorders.

Timeline

Start
2021-09-03
Primary completion
2024-06-14
Completion
2024-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Mexiletine Small molecule

Indications