Myopathic ConditionsPhase 4NCT00127335
Is Myopathy Part of Statin Therapy (IMPOSTER-16)
A Phase 4 study of Myopathic Conditions, run by Scripps Health at 1 site in United States.
Trial summary
There is a significant proportion of patients complaining of muscle symptoms while on statin therapy who have a measurable difference in muscle strength or endurance and whose muscle biopsies are diagnostic for myopathy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myopathic Conditions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary doctor's permission
- Patient understands nature of study and has signed consent
- Patient is >21 years of age
- Patient willing to stop statin for up to 12 weeks and remain off CoQ10 for study duration
- Patient able to perform the strength and functional tests required
- Patient complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy
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- CK < 350 IU
- Thyroid stimulating hormone (TSH) must be normal
- Fasting respiratory exchange ratio (RER) > 0.80 off statin for at least 4 weeks
Who cannot join
- Severe underlying illness including: Cr > 3.0, liver failure, unstable angina, symptomatic valvular heart disease, congestive heart failure, or prior cerebrovascular accident (CVA) preventing exercise testing.
- History of muscle damage (CK > 350 IU) on statins
- Underlying musculoskeletal disorder preventing muscle testing
- History of severe depression
- Taking doses of other medicines with statin sufficient to cause myopathy including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily.
- Diabetes requiring other than diet therapy
Show all 9Show fewer
- Use of thiazolidinediones (TZD's), protease inhibitors or other drugs known to influence RER or fatty acid oxidation.
- Abnormal thyroid status
- Inability to maintain constant exercise, dietary, and drug regimen during the 16 weeks required by the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Prospective Randomized, Crossover Study of Patients With Muscle Complaints on Statin Therapy
There is a significant proportion of patients complaining of muscle symptoms while on statin therapy who have a measurable difference in muscle strength or endurance and whose muscle biopsies are diagnostic for myopathy.
Read the detailed description
This is a double-blinded, randomized, placebo-controlled, crossover trial. Sixty patients who are identified by their physician as having muscle pain or weakness while on statin therapy and in whom creatine kinase (CK) enzyme determinations have been normal will be enrolled voluntarily. All patients will have a percutaneous muscle biopsy prior to enrollment into the trial. These patients will be randomized in a blinded crossover fashion to either standardized statin therapy or placebo in eight week intervals. After eight weeks of drug or placebo the patients will be assessed for signs and symptoms of muscle weakness by:
- Dynamometry of grip and hip strength
- An exercise test with exhaled gas analysis
- Blood tests for cholesterol, creatine kinase, lactate
- Urine tests for organic acids
Following the first eight-week study and testing period, each patient will serve as their own control and they will enter a second eight-week study period. During the second phase they will take the opposite therapy, either drug or placebo, which they have not yet received. Sub-studies will include ten controls who have never previously received statins and ten subjects who have suffered statin-induced rhabdomyolysis. Subjects in these sub-studies will not be exposed to statin therapy and will only undergo limited testing.
- Conditions
- Myopathic Conditions
- Being tested
- cellulose placebo vs. atorvastatin
- Keywords
- rhabdomyolysis,, myositis,, myopathy,, statin side effects,, fatty acid oxidation, Statin induced Muscle toxicity
- Medical subject headings
- Muscular Diseases, Rhabdomyolysis, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cellulose placebo vs. atorvastatinDrug
Also called atorvastatin
drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: cellulose placebo vs. atorvastatin |
| 2 | Active comparator | statin administration Receives: Drug: cellulose placebo vs. atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip flexion
Measured: 8 weeks
oxygen consumption and anaerobic threshold
Measured: 8 weeks
muscle pathology score
Measured: at entry
Secondary outcomes (3)
ability to identify blinded statin
Measured: 8 weeks
other aerobic exercise indexes
Measured: 8 weeks
fatty acid oxidation of myocyte cell cultures
Measured: at entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myopathic ConditionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul S Phillips, MD, Principal investigator, Scripps HealthHarminder Sikand, PharmD, Study director, Scripps Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127335
- Sponsor's protocol ID
- M-05-001 (MER004241)
- Status last verified
- Nov 2022
- First submitted
- 4 Aug 2005
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Phillips PS. Ezetimibe and statin-associated myopathy. Ann Intern Med. 2004 Oct 19;141(8):649. doi: 10.7326/0003-4819-141-8-200410190-00021. No abstract available.
PubMed 15492351Phillips PS, Phillips CT, Sullivan MJ, Naviaux RK, Haas RH. Statin myotoxicity is associated with changes in the cardiopulmonary function. Atherosclerosis. 2004 Nov;177(1):183-8. doi: 10.1016/j.atherosclerosis.2004.06.014.
PubMed 15488882Phillips PS, Haas RH, Bannykh S, Hathaway S, Gray NL, Kimura BJ, Vladutiu GD, England JD; Scripps Mercy Clinical Research Center. Statin-associated myopathy with normal creatine kinase levels. Ann Intern Med. 2002 Oct 1;137(7):581-5. doi: 10.7326/0003-4819-137-7-200210010-00009.
PubMed 12353945Antons KA, Williams CD, Baker SK, Phillips PS. Clinical perspectives of statin-induced rhabdomyolysis. Am J Med. 2006 May;119(5):400-9. doi: 10.1016/j.amjmed.2006.02.007.
PubMed 16651050
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Prospective Randomized, Crossover Study of Patients With Muscle Complaints on Statin Therapy
- ClinicalTrials.gov ID
- NCT00127335
- Acronym / sponsor ID
- M-05-001 (MER004241)
- Conditions
- Myopathic Conditions
- Keywords
- rhabdomyolysis,, myositis,, myopathy,, statin side effects,, fatty acid oxidation, Statin induced Muscle toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 5 Aug 2005 (estimated)
- 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.
There is a significant proportion of patients complaining of muscle symptoms while on statin therapy who have a measurable difference in muscle strength or endurance and whose muscle biopsies are diagnostic for myopathy.
Detailed description
This is a double-blinded, randomized, placebo-controlled, crossover trial. Sixty patients who are identified by their physician as having muscle pain or weakness while on statin therapy and in whom creatine kinase (CK) enzyme determinations have been normal will be enrolled voluntarily. All patients will have a percutaneous muscle biopsy prior to enrollment into the trial. These patients will be randomized in a blinded crossover fashion to either standardized statin therapy or placebo in eight week intervals. After eight weeks of drug or placebo the patients will be assessed for signs and symptoms of muscle weakness by:
- Dynamometry of grip and hip strength
- An exercise test with exhaled gas analysis
- Blood tests for cholesterol, creatine kinase, lactate
- Urine tests for organic acids
Following the first eight-week study and testing period, each patient will serve as their own control and they will enter a second eight-week study period. During the second phase they will take the opposite therapy, either drug or placebo, which they have not yet received. Sub-studies will include ten controls who have never previously received statins and ten subjects who have suffered statin-induced rhabdomyolysis. Subjects in these sub-studies will not be exposed to statin therapy and will only undergo limited testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: cellulose placebo vs. atorvastatin |
| 2 | Active comparator | Drug: cellulose placebo vs. atorvastatinstatin administration |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Primary doctor's permission
- Patient understands nature of study and has signed consent
- Patient is >21 years of age
- Patient willing to stop statin for up to 12 weeks and remain off CoQ10 for study duration
- Patient able to perform the strength and functional tests required
Key exclusion criteria (9 listed)
- Severe underlying illness including: Cr > 3.0, liver failure, unstable angina, symptomatic valvular heart disease, congestive heart failure, or prior cerebrovascular accident (CVA) preventing exercise testing.
- History of muscle damage (CK > 350 IU) on statins
- Underlying musculoskeletal disorder preventing muscle testing
- History of severe depression
- Taking doses of other medicines with statin sufficient to cause myopathy including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily.
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 |
|---|---|---|
| cellulose placebo vs. atorvastatinAlso: atorvastatindrug | Drug | 1, 2 |
Primary outcome
hip flexion
Time frame: 8 weeks
oxygen consumption and anaerobic threshold
Time frame: 8 weeks
muscle pathology score
Time frame: at entry
3 secondary outcomes
ability to identify blinded statin
Time frame: 8 weeks
other aerobic exercise indexes
Time frame: 8 weeks
fatty acid oxidation of myocyte cell cultures
Time frame: at entry
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Background: PubMed 15492351Phillips PS. Ezetimibe and statin-associated myopathy. Ann Intern Med. 2004 Oct 19;141(8):649. doi: 10.7326/0003-4819-141-8-200410190-00021. No abstract available.
- Background: PubMed 15488882Phillips PS, Phillips CT, Sullivan MJ, Naviaux RK, Haas RH. Statin myotoxicity is associated with changes in the cardiopulmonary function. Atherosclerosis. 2004 Nov;177(1):183-8. doi: 10.1016/j.atherosclerosis.2004.06.014.
- Background: PubMed 12353945Phillips PS, Haas RH, Bannykh S, Hathaway S, Gray NL, Kimura BJ, Vladutiu GD, England JD; Scripps Mercy Clinical Research Center. Statin-associated myopathy with normal creatine kinase levels. Ann Intern Med. 2002 Oct 1;137(7):581-5. doi: 10.7326/0003-4819-137-7-200210010-00009.
- Background: PubMed 16651050Antons KA, Williams CD, Baker SK, Phillips PS. Clinical perspectives of statin-induced rhabdomyolysis. Am J Med. 2006 May;119(5):400-9. doi: 10.1016/j.amjmed.2006.02.007.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Paul S Phillips, MD principal investigator
Scripps Health
Harminder Sikand, PharmD study director
Scripps Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Myopathic Conditions, run by Scripps Health at 1 site in United States.
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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
hip flexion (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00127335, which also lists 4 linked publications.
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 23 Nov 2022.