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

NCT ID: NCT01259791

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-08-31

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.

Conditions

Statin Myopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Individual-specific statin causing myopathy

Intervention Type: DRUG

Individual-specific statin causing myopathy vs. placebo

Placebo

Identical placebo to patient-specific statin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Individual-specific statin causing myopathy

Individual-specific statin causing myopathy vs. placebo

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• same as above

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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Tisha Joy

Assistant Professor, Division of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tisha Joy, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Health Care, UWO

Locations

St. Joseph's Health Care

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 24737272 (View on PubMed)

Other Identifiers

17352

Identifier Type: OTHER

Identifier Source: secondary_id

R-10-450

Identifier Type: -

Identifier Source: org_study_id