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

NCT01259791 | Completed

• 2 other identifiers: R-10-45017352
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.

  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.

  September 2010 to August 2013

Study Arms (2)

Statin

EXPERIMENTAL

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).

Drug: Individual-specific statin causing myopathy

Placebo

PLACEBO COMPARATOR

Identical placebo to patient-specific statin

Drug: Placebo

Interventions

Individual-specific statin causing myopathy DRUG

Individual-specific statin causing myopathy vs. placebo

Statin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• same as above but also:
• angina III of IV
• decompensated heart failure
• history of orthopedic problems

Sponsors & Collaborators

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

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

• 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.

  PMID: 24737272 DERIVED

Study Officials

• Tisha Joy, MD, FRCPC

  St. Joseph's Health Care, UWO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Endocrinology

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

CA (1)