Dantrolene in Statin-induced Myopathy

NCT06966843 | Not Yet Recruiting Phase 2

• 1 other identifier: Dan1199
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Statins Induced Myopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 weeks after intervention start

Secondary Outcomes (3)

• Change in Muscle Pain Score (Visual Analog Scale)

  Baseline and Week 4

• Change in Serum Lactate Dehydrogenase (LDH) Level

  Baseline and Week 4

• Number of Participants With Adverse Effects Related to Dantrolene

  Throughout the 4-week intervention period

Study Arms (2)

Dantrolene Group

EXPERIMENTAL

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.

Drug: Dantrolene

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dantrolene DRUG

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.

Also known as: Dantrium, Ryanodex

Dantrolene Group

Placebo DRUG

Oral placebo capsule matching dantrolene in size and appearance, administered once daily for 4 weeks.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Interventions

Dantrolene

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teacher assistant in Delta University for science and technology

Model Details: Participants will be randomized to receive either dantrolene or placebo for 4 weeks.

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: May 13, 2025

Record last verified: 2025-05