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

March 13, 2017 updated by: Tisha Joy, Lawson Health Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Individual-specific statin causing myopathy
Individual-specific statin causing myopathy vs. placebo
Placebo Comparator: Placebo
Identical placebo to patient-specific statin
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Duration of study September 2010 to August 2013

Secondary Outcome Measures

Outcome Measure
Time Frame
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
September 2010 to August 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Tisha Joy, MD, FRCPC, St. Joseph's Health Care, UWO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-10-450
  • 17352 (Other Identifier: Office of Research Ethics, UWO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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