Dantrolene in Statin-induced Myopathy

Launched by TANTA UNIVERSITY · May 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called dantrolene to help patients who are experiencing muscle problems due to statin medications. Statins are commonly prescribed to lower cholesterol, but they can sometimes cause muscle pain and weakness, a condition known as statin-induced myopathy. The researchers believe that dantrolene may help reduce these muscle issues by targeting how calcium is released in the muscles, which could help improve symptoms.

To participate in this trial, you need to be between 18 and 75 years old and have been taking statins for at least four weeks. You should also be experiencing muscle pain or weakness and have elevated levels of a substance in your blood called creatine kinase, which indicates muscle damage. If you join the study, you may need to stop taking statins temporarily. The trial is not yet recruiting participants, but it's important to know that if you have liver problems, are pregnant or breastfeeding, or have other specific health issues, you may not be eligible. Participants will be closely monitored during the trial to understand how well dantrolene works in reducing muscle problems caused by statins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 18-75 years Currently receiving statin therapy for at least 4 weeks Clinical symptoms suggestive of statin-induced myopathy (e.g., muscle pain, weakness) Elevated serum creatine kinase (CK) ≥1.5x upper limit of normal Able and willing to provide informed consent Willing to discontinue statins during the study period (if protocol requires)
• Exclusion Criteria:
• • Known hypersensitivity to dantrolene History of severe liver disease or abnormal liver function tests (ALT or AST \> 2x ULN) Use of interacting drugs that may increase dantrolene toxicity (e.g., calcium channel blockers like verapamil) Renal impairment (e.g., serum creatinine \>2.0 mg/dL) Diagnosed neuromuscular disorders unrelated to statins (e.g., ALS, muscular dystrophy) Pregnant or breastfeeding women Participation in another clinical trial within the past 30 days