Statins Induced MyopathyPhase 2/3NCT06966843
Dantrolene in Statin-induced Myopathy
A Phase 2/3 study testing Dantrolene in people with Statins Induced Myopathy, run by Tanta University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Statins Induced Myopathy
- What is being tested?
- Dantrolene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Oct 2027to Mar 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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
- Being tested
- Dantrolene, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DantroleneDrug
Also called Dantrium, Ryanodex
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.
PlaceboDrug
Oral placebo capsule matching dantrolene in size and appearance, administered once daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks after intervention start
Secondary outcomes (3)
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
Measured: Baseline and Week 4
Change in Serum Lactate Dehydrogenase (LDH) Level
LDH as an additional marker of muscle damage.
Measured: Baseline and Week 4
Number of Participants With Adverse Effects Related to Dantrolene
Safety evaluation of dantrolene use over the study period.
Measured: Throughout the 4-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study startOct 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statins Induced MyopathyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive either dantrolene or placebo for 4 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Alaa Abdel Samie, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966843
- Sponsor's protocol ID
- Dan1199
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dantrolene in Statin-induced Myopathy
- ClinicalTrials.gov ID
- NCT06966843
- Acronym / sponsor ID
- Dan1199
- Conditions
- Statins Induced Myopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Oct 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either dantrolene or placebo for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Dantrolene Group | Experimental | Drug: DantroleneParticipants 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 comparator | Drug: PlaceboParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DantroleneAlso: Dantrium, RyanodexDantrolene 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 | Dantrolene Group |
| PlaceboOral placebo capsule matching dantrolene in size and appearance, administered once daily for 4 weeks. | Drug | Placebo Group |
Primary outcome
Change in Creatine Kinase (CK) Level
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dantrolene in people with Statins Induced Myopathy, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Creatine Kinase (CK) Level (time frame: Baseline and 4 weeks after intervention start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.