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

> **NCT06523400** · PHASE3 · RECRUITING · sponsor: **Lupin Ltd.** · enrollment: 176 (estimated)

## Conditions studied

- Myotonic Dystrophy

## Interventions

- **DRUG:** Mexiletine granules for prolonged-release oral suspension
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT06523400
- **Lead sponsor:** Lupin Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-02-13
- **Primary completion:** 2026-03-17
- **Final completion:** 2026-04-22
- **Target enrollment:** 176 (ESTIMATED)
- **Last updated:** 2026-02-06

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06523400

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06523400, "The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT06523400. Licensed CC0.

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