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

NAActive, not recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

November 5, 2021

Primary Completion Date

January 26, 2026

Study Completion Date

March 12, 2026

Conditions
Myotonic Disorders
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"

Trial Locations (1)

Unknown

Hôpital Necker-Enfants-Malades, Paris

All Listed Sponsors
lead

Lupin Ltd.

INDUSTRY

NCT04622553 - Open-label Extension Study in Paediatric Patients Who Have Completed the MEX-NM-301 Study. | Biotech Hunter | Biotech Hunter