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

This study has been completed.
Information provided by (Responsible Party):
Tisha Joy, Lawson Health Research Institute Identifier:
First received: December 13, 2010
Last updated: March 13, 2017
Last verified: March 2017
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.

Condition Intervention
Statin Myopathy
Drug: Individual-specific statin causing myopathy
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Other
Official Title: Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: September 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: Individual-specific statin causing myopathy
Individual-specific statin causing myopathy vs. placebo
Placebo Comparator: Placebo
Identical placebo to patient-specific statin
Drug: Placebo


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01259791

Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Tisha Joy, MD, FRCPC St. Joseph's Health Care, UWO
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tisha Joy, Assistant Professor, Division of Endocrinology, Lawson Health Research Institute Identifier: NCT01259791     History of Changes
Other Study ID Numbers: R-10-450
17352 ( Other Identifier: Office of Research Ethics, UWO )
Study First Received: December 13, 2010
Last Updated: March 13, 2017

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on April 26, 2017