mexiletine prolonged release / Lupin - LARVOL DELTA

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed MEX-DM-302 Study. (clinicaltrials.gov) - P3 | N=176 | Enrolling by invitation | Sponsor: Lupin Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: Lupin Ltd. | Trial completion date: Oct 2026 ➔ Feb 2027 | Trial primary completion date: Jul 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Myotonic Dystrophy

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: Lupin Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Myotonic Dystrophy

The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 (clinicaltrials.gov) - P3 | N=176 | Recruiting | Sponsor: Lupin Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed MEX-DM-302 Study. (clinicaltrials.gov) - P3 | N=176 | Not yet recruiting | Sponsor: Lupin Ltd. | Trial completion date: Jun 2027 ➔ Jul 2028 | Trial primary completion date: Apr 2027 ➔ May 2028

Trial completion date • Trial primary completion date • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy