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ACTIVE NOT RECRUITING
NCT04622553
NA

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

Sponsor: Lupin Ltd.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2021-11-05

Completion Date

2026-03-12

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

DRUG

Mexiletine

Patients will be enrolled sequentially into 2 cohorts. Cohort 1 - (patients aged 12 to \< 18 years): approximately 8 weeks - 4 weeks of dose titration period + 4 weeks of maintenance period. Cohort 2- (patients aged 6 to \< 12 years,): approximately 8 weeks - 4 weeks of dose titration period + 4 weeks of maintenance period. Enrolment for Cohort 2 will begin after initial pharmacokinetics (PK), safety and efficacy are confirmed in this population, of patients in Cohort 1

Locations (1)

Hôpital Necker-Enfants-Malades

Paris, France