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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259791
First Posted: December 14, 2010
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tisha Joy, Lawson Health Research Institute
  Purpose
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: Double (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 Tisha Joy, 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
Placebo

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259791


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tisha Joy, Assistant Professor, Division of Endocrinology, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01259791     History of Changes
Other Study ID Numbers: R-10-450
17352 ( Other Identifier: Office of Research Ethics, UWO )
First Submitted: December 13, 2010
First Posted: December 14, 2010
Last Update Posted: March 15, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents