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OpenTrials
Completed

NCT Number: NCT01259791

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.

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Key information

Conditions

Statin Myopathy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individual-specific statin causing myopathy

Drug

Individual-specific statin causing myopathy vs. placebo

Placebo

Drug

Placebo

Primary outcomes

  1. 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 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.

    Time frame: September 2010 to August 2013

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 14, 2010
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.