NCT07075965

Calcium Channel Blocker in Myotonic Dystrophy Type 1

Calcium Channel Blocker in Myotonic Dystrophy Type 1 (CAP DM1)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of amlodipine, a calcium channel blocker, in adults with Myotonic Dystrophy Type 1 (DM1). Amlodipine is being studied to see if it can improve muscle strength, reduce stiffness (myotonia), and improve function by modifying calcium flow in muscle cells. All participants will receive amlodipine starting at 2.5 mg daily for 2 weeks, then 5 mg for 4 weeks. After that, participants will be randomly assigned to continue on 5 mg or increase to 10 mg for an additional 4 weeks. The main goals are to assess changes in blood pressure and any adverse events to determine whether the drug is safe in this population. The study will also explore how amlodipine affects muscle strength, mobility, fatigue, and daily function using clinical tests and questionnaires. Findings will inform a future phase 2 trial.

Conditions

• Myotonic Dystrophy 1

Interventions

Type	Name	Description
DRUG	Amlodipine	Evaluating 2 different doses of amlodipine, after an initial titration phase (2.5 mg daily), amlodipine is increased to the target doses of 5 mg and 10 mg

Timeline

• Start date: 2026-12-07
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2025-07-20
• Last updated: 2025-12-09

Regulatory

• FDA-regulated drug study