Clinical Trial

Open-label Extension Study in Paediatric Patients Who Have Completed the MEX-NM-301 Study.

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated July 25, 2025 (before its estimated January 26, 2026 completion). Its status may not reflect the trial's current state.
Summary
Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Mexiletine in Paediatric Patients with Myotonic Disorders Who Have Completed the MEX-NM-301 study.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-11-03; most recent amendment 2025-07-24.
Status change: Recruiting → Active, Not Recruiting 2024-05-03
Status change: Not Yet Recruiting → Recruiting 2021-12-01
Trial Details
NCT Number NCT04622553
Lead Sponsor Lupin Ltd.
Conditions Myotonic Disorders
Enrollment 14 participants
Start Date 2021-11-05
Primary Completion 2026-01-26 (estimated)
Study Completion 2026-03-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-25