drugset / Trial / NCT06966843

Dantrolene in Statin-induced Myopathy

NCT06966843

Phase 2/3 Not yet recruiting 23 enrolled Tanta University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Statins are one of the most efficient drugs for the treatment of hypercholesterolemia which is considered as one of the main risk factors for atherosclerosis., and therefore they are frequently prescribed medications \[1-2\]. However, statins therapy is associated with myotoxicity. This effect of different severity ranges forms myopathy, myalgia, myositis, and rhabdomyolysis \[3\]. Different studies set a number of hypotheses to explain the pathophysiological events of statin-induced myopathy. These hypotheses include disturbance of mitochondrial function resulting in cytoplasmic Ca2+ overload as well as decreased level of the potent antioxidant and membrane stabilizer coenzyme Q10/ubiquinone \[4-5\] This study tries to introduce a complementary therapy that targets these molecular events. This therapeutic protocol includes dantrolene the muscle relaxant that acts as a ryanodine receptor (RYR) antagonist and thus decreases Ca release in cytoplasm.

Timeline

Start
2027-10
Primary completion
2029-01
Completion
2030-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Dantrolene Small molecule 50 mg Oral

Indications