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

Primary Purpose

Statin Myopathy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Individual-specific statin causing myopathy
Placebo
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Statin Myopathy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Statin

Placebo

Arm Description

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).

Identical placebo to patient-specific statin

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
December 13, 2010
Last Updated
March 13, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01259791
Brief Title
Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
Official Title
Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Statin Myopathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Statin
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo to patient-specific statin
Intervention Type
Drug
Intervention Name(s)
Individual-specific statin causing myopathy
Intervention Description
Individual-specific statin causing myopathy vs. placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tisha Joy, MD, FRCPC
Organizational Affiliation
St. Joseph's Health Care, UWO
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24737272
Citation
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.
Results Reference
derived

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

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