An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR

PHASE3RecruitingINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

July 8, 2026

Study Completion Date

October 4, 2026

Conditions

Myotonia

Interventions

DRUG

Granular powder in unit dose foil-lined sachet Mexiletine (PR)

Mexiletine (PR)

DRUG

Oral Capsule Mexiletine (IR)

Mexiletine (IR)

Trial Locations (1)

RECRUITING

"Universitair Ziekenhuis LeuvenUZ Leuven Gasthuisberg Campus Herestraat 49 Leuven, 3000", Leuven

All Listed Sponsors

collaborator

Lupin Atlantis Holdings S.A.

UNKNOWN

lead

Lupin Ltd.

INDUSTRY