drugset / Trial / NCT06523400
The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2
RandomizedSingle-groupQuadruple-blindTreatment
Summary
A Randomized, Double-blind, Placebo-Controlled, Multi-Center Study to Investigate the Efficacy and Safety of Once Daily Mexiletine PR During 26 Weeks of Treatment in Patients with Myotonic Dystrophy Type 1 and Type 2 (HERCULES study) Study website: https://myotonicdystrophystudy.com/
Timeline
- Start
- 2025-02-13
- Primary completion
- 2027-06
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mexiletine | Small molecule | 167 mg | Oral |
| Comparator | Mexiletine | Small molecule | 333 mg | Oral |
| Comparator | Mexiletine | Small molecule | 500 mg | Oral |