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

Statin Myopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259791
• Other study ID #: R-10-450
• Secondary ID: 17352
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: March 13, 2017
• Start date: September 2010
• Est. completion date: August 2013

Study information

• Verified date: March 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscular Diseases
• Statin Myopathy

Intervention

Drug:
• Individual-specific statin causing myopathy
Individual-specific statin causing myopathy vs. placebo
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.		Duration of study September 2010 to August 2013
Secondary	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.		September 2010 to August 2013