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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01259791
First received: December 13, 2010
Last updated: June 29, 2011
Last verified: June 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: September 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Statin, myalgias
Statin causing myopathic symptoms in patient (can be any of the following statins: rosuvastatin, atorvastatin, simvastatin, fluvastatin, pravastatin in any of the does causing myalgias in patient.
Drug: Individual-specific statin causing myopathy
Individual-specific statin causing myopathy vs. placebo
Placebo Comparator: statin
Identical placebo to patient-specific statin
Drug: Individual-specific statin causing myopathy
Individual-specific statin causing myopathy vs. placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259791

Contacts
Contact: Tisha Joy, MD, FRCPC, Cert Endo 519-646-6296 tisha.joy@sjhc.london.on.ca
Contact: Lynda Bere, RN 519-646-6000 ext 65996

Locations
Canada, Ontario
St. Joseph's Health Care Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Tisha Joy, MD, FRCPC    519-646-6296    tisha.joy@sjhc.london.on.ca   
Contact: Lynda Bere, RN    519-646-6000 ext 65996      
Principal Investigator: Tisha Joy, MD, FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Tisha Joy, MD, FRCPC, Cert Endo St. Joseph's Health Care, UWO
  More Information

No publications provided by Lawson Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Tisha Joy/ Principal Investigator, St. Joseph's Health Care, Department of Medicine, UWO
ClinicalTrials.gov Identifier: NCT01259791     History of Changes
Other Study ID Numbers: R-10-450, 17352
Study First Received: December 13, 2010
Last Updated: June 29, 2011
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on October 23, 2014