14
Participants
Start Date
November 5, 2021
Primary Completion Date
January 26, 2026
Study Completion Date
March 12, 2026
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"
Hôpital Necker-Enfants-Malades, Paris
Lupin Ltd.
INDUSTRY