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

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.
 
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

Tracking Information
First Submitted Date  ICMJE December 13, 2010
First Posted Date  ICMJE December 14, 2010
Last Update Posted Date March 15, 2017
Study Start Date  ICMJE September 2010
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
Official Title  ICMJE Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Statin Myopathy
Intervention  ICMJE
  • Drug: Individual-specific statin causing myopathy
    Individual-specific statin causing myopathy vs. placebo
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2010)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01259791
Other Study ID Numbers  ICMJE R-10-450
17352 ( Other Identifier: Office of Research Ethics, UWO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tisha Joy, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tisha Joy, MD, FRCPC St. Joseph's Health Care, UWO
PRS Account Lawson Health Research Institute
Verification Date March 2017

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