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Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design

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ClinicalTrials.gov Identifier: NCT01259791
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Tisha Joy, Lawson Health Research Institute

December 13, 2010
December 14, 2010
March 15, 2017
September 2010
August 2013   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT01259791 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Statin Myopathy
  • Drug: Individual-specific statin causing myopathy
    Individual-specific statin causing myopathy vs. placebo
  • Drug: Placebo
    Placebo
  • Experimental: Statin
    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).
    Intervention: Drug: Individual-specific statin causing myopathy
  • Placebo Comparator: Placebo
    Identical placebo to patient-specific statin
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Same as current
August 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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:

Inclusion Criteria:

- same as above

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01259791
R-10-450
17352 ( Other Identifier: Office of Research Ethics, UWO )
No
Not Provided
Not Provided
Tisha Joy, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Tisha Joy, MD, FRCPC St. Joseph's Health Care, UWO
Lawson Health Research Institute
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP