Status:
NOT_YET_RECRUITING
Dantrolene in Statin-induced Myopathy
Lead Sponsor:
Tanta University
Conditions:
Statins Induced Myopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 prescr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06966843
Start Date
October 1 2027
End Date
March 1 2030
Last Update
May 13 2025
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