Dantrolene in Statin-induced Myopathy
- Conditions
- Statins Induced Myopathy
- Interventions
- Drug: Placebo
- Registration Number
- NCT06966843
- Lead Sponsor
- Tanta University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 23
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)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dantrolene Group Dantrolene Participants will receive oral dantrolene 25 mg capsule once daily for 4 weeks. Dose may be increased to 50 mg daily based on tolerance and response. Dantrolene is used to evaluate its potential effect on muscle symptoms and biomarkers in statin-induced myopathy. Placebo Group Placebo Participants will receive a matching oral placebo capsule once daily for 4 weeks, designed to mimic dantrolene in appearance. This arm serves as the control to assess the efficacy and safety of dantrolene in comparison to placebo
- Primary Outcome Measures
Name Time Method Change in Creatine Kinase (CK) Level Baseline and 4 weeks after intervention start Evaluation of the effect of dantrolene on serum creatine kinase, a biomarker of muscle injury, in statin-induced myopathy.
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Effects Related to Dantrolene Throughout the 4-week intervention period Safety evaluation of dantrolene use over the study period.
Change in Muscle Pain Score (Visual Analog Scale) Baseline and Week 4 Assessment of self-reported muscle pain severity using a 10-point VAS. Time Frame: Baseline and Week 4
Change in Serum Lactate Dehydrogenase (LDH) Level Baseline and Week 4 LDH as an additional marker of muscle damage.