NCT06523400View on ClinicalTrials.gov

The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2

PHASE3RecruitingINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

February 13, 2025

Primary Completion Date

March 17, 2026

Study Completion Date

April 22, 2026

Conditions
Myotonic Dystrophy
Interventions
DRUG

Mexiletine granules for prolonged-release oral suspension

Mexiletine PR

DRUG

Placebo

Matching Placebo

Trial Locations (6)

Unknown

RECRUITING

Laboratory for Muscle Diseases and Neuropathies, Leuven

RECRUITING

Aarhus University Hospital, Aarhus

RECRUITING

Ludug-Maximilians University, München

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome

RECRUITING

University Hospital of Madrid, Madrid

RECRUITING

University College Hospital, London

All Listed Sponsors
collaborator

Lupin Atlantis Holdings S.A.

UNKNOWN

lead

Lupin Ltd.

INDUSTRY

NCT06523400 - The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 | Biotech Hunter | Biotech Hunter