Dantrolene in Statin-induced Myopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dantrolene, Placebo.
- Who it may be relevant to
- Registry conditions: Statins Induced Myopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Dantrolene
Dantrolene sodium capsule 25 mg orally once daily for 4 weeks. Dose may be titrated to 50 mg daily after 1 week if tolerated. Used to assess impact on muscle pain and biomarkers of muscle injury in patients with statin-induced myopathy. - Drug Placebo
Oral placebo capsule matching dantrolene in size and appearance, administered once daily for 4 weeks.
Primary outcome measures
- Change in Creatine Kinase (CK) Level [Time frame: Baseline and 4 weeks after intervention start]
Secondary outcome measures (3)
- Change in Muscle Pain Score (Visual Analog Scale) [Time frame: Baseline and Week 4]
- Change in Serum Lactate Dehydrogenase (LDH) Level [Time frame: Baseline and Week 4]
- Number of Participants With Adverse Effects Related to Dantrolene [Time frame: Throughout the 4-week intervention period]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06966843 · Dan1199