Dantrolene in Statin-induced Myopathy

Phase 3Not Yet RecruitingNCT06966843

Tanta University23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Statins Induced Myopathy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Creatine Kinase (CK) Level

Evaluation of the effect of dantrolene on serum creatine kinase, a biomarker of muscle injury, in statin-induced myopathy.

Time frame: Baseline and 4 weeks after intervention start

Secondary Outcomes

Change in Muscle Pain Score (Visual Analog Scale)

Assessment of self-reported muscle pain severity using a 10-point VAS. Time Frame: Baseline and Week 4

Time frame: Baseline and Week 4

Change in Serum Lactate Dehydrogenase (LDH) Level

LDH as an additional marker of muscle damage.

Time frame: Baseline and Week 4

Number of Participants With Adverse Effects Related to Dantrolene

Safety evaluation of dantrolene use over the study period.

Time frame: Throughout the 4-week intervention period