Statin MyopathyNCT01259791
Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
A study testing Individual-specific statin causing myopathy in people with Statin Myopathy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study consists of a series of prospective, randomized placebo-controlled n of 1 trials to objectively evaluate the reproducibility of subjective and objective symptoms among patients with a history of statin-related myopathy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Statin Myopathy
- What is being tested?
- Individual-specific statin causing myopathy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Aug 2013
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of muscle symptoms occuring within 3 weeks of starting a statin
- need for statin therapy to achieve LDL target according to the 2009 Canadian Lipid Guidelines
- willingness to re-try statin therapy
- same as above
Who cannot join
- currently tolerant of statin therapy
- metabolic or inflammatory myopathy
- known neuropathy
- CK elevation >3 times upper limit of normal (ULN) previously on a statin or history of rhabdomyolysis
- pregnant, breastfeeding, or wanting to become pregnant in the near future
- participation in another clinical trial
Show all 15Show fewer
- other medical condition associated with decreased life span
- inability to adhere to stringent regimen
- unwilling to stop consumption of grapefruit juice
- Subset of 5 patients also completing neuromuscular testing:
- same as above but also:
- angina III of IV
- decompensated heart failure
- history of orthopedic problems
- have any skin ulcers or other non-healed skin areas or infections in the arm or leg
Trial locations and contacts
1 site in 1 country.
About this study
This study consists of a series of prospective, randomized placebo-controlled n of 1 trials to objectively evaluate the reproducibility of subjective and objective symptoms among patients with a history of statin-related myopathy.
- Conditions
- Statin Myopathy
- Being tested
- Individual-specific statin causing myopathy, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual-specific statin causing myopathyDrug
Individual-specific statin causing myopathy vs. placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Statin | Experimental | Individual-specific statin causing myopathy - i.e., Patients will receive the specific statin previously associated with myopathic symptoms in them (can be any of the following statins: rosuvastatin, atorvastatin, simvastatin, fluvastatin, pravastatin in any of the doses causing symptoms previously). Receives: Drug: Individual-specific statin causing myopathy |
| Placebo | Placebo comparator | Identical placebo to patient-specific statin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.
Measured: Duration of study September 2010 to August 2013
Secondary outcomes (1)
To delineate the relation of objective changes in non-invasive neuromuscular testing to subjective symptoms during the first exposure to active or placebo therapy, in subset of 5 patients with prior history of statin myopathy.
Measured: September 2010 to August 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Statin MyopathyStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tisha Joy, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Tisha Joy, MD, FRCPC, Principal investigator, St. Joseph's Health Care, UWO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259791
- Sponsor's protocol ID
- R-10-450
- Other IDs
- 17352
- Status last verified
- Mar 2017
- First submitted
- 13 Dec 2010
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Joy TR, Monjed A, Zou GY, Hegele RA, McDonald CG, Mahon JL. N-of-1 (single-patient) trials for statin-related myalgia. Ann Intern Med. 2014 Mar 4;160(5):301-10. doi: 10.7326/M13-1921.
PubMed 24737272
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
- ClinicalTrials.gov ID
- NCT01259791
- Acronym / sponsor ID
- R-10-450
- Conditions
- Statin Myopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Dec 2010 (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.
This study consists of a series of prospective, randomized placebo-controlled n of 1 trials to objectively evaluate the reproducibility of subjective and objective symptoms among patients with a history of statin-related myopathy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin | Experimental | Drug: Individual-specific statin causing myopathyIndividual-specific statin causing myopathy - i.e., Patients will receive the specific statin previously associated with myopathic symptoms in them (can be any of the following statins: rosuvastatin, atorvastatin, simvastatin, fluvastatin, pravastatin in any of the doses causing symptoms previously). |
| Placebo | Placebo comparator | Drug: PlaceboIdentical placebo to patient-specific statin |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- history of muscle symptoms occuring within 3 weeks of starting a statin
- need for statin therapy to achieve LDL target according to the 2009 Canadian Lipid Guidelines
- willingness to re-try statin therapy
- same as above
Key exclusion criteria (15 listed)
- currently tolerant of statin therapy
- metabolic or inflammatory myopathy
- known neuropathy
- CK elevation >3 times upper limit of normal (ULN) previously on a statin or history of rhabdomyolysis
- pregnant, breastfeeding, or wanting to become pregnant in the near future
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 |
|---|---|---|
| Individual-specific statin causing myopathyIndividual-specific statin causing myopathy vs. placebo | Drug | Statin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.
Time frame: Duration of study September 2010 to August 2013
1 secondary outcome
To delineate the relation of objective changes in non-invasive neuromuscular testing to subjective symptoms during the first exposure to active or placebo therapy, in subset of 5 patients with prior history of statin myopathy.
Time frame: September 2010 to August 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Derived from this study: PubMed 24737272Joy TR, Monjed A, Zou GY, Hegele RA, McDonald CG, Mahon JL. N-of-1 (single-patient) trials for statin-related myalgia. Ann Intern Med. 2014 Mar 4;160(5):301-10. doi: 10.7326/M13-1921.
Related trials for Statin Myopathy
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Annatto-derived GG for Statin-associated Myopathy
Myopathy; Primary
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Dantrolene in Statin-induced Myopathy
Statins Induced Myopathy
Not yet recruitingObservational study
Evaluation of Neuromuscular Blockade Responses in Statin-Using and Non-Using Patients
Neuromuscular Blockade, Statin-Associated Myopathy
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.
Tisha Joy, MD, FRCPC principal investigator
St. Joseph's Health Care, UWO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual-specific statin causing myopathy in people with Statin Myopathy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 15 Mar 2017. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy. (time frame: Duration of study September 2010 to August 2013). 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 NCT01259791, which also lists 1 linked publication.
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 15 Mar 2017.