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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01259791

Enrollment

Registered

2010-12-14

Start date

2010-09-30

Completion date

2013-08-31

Last updated

2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Statin Myopathy

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.

Interventions

DRUGIndividual-specific statin causing myopathy

Individual-specific statin causing myopathy vs. placebo

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

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

Secondary

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.	September 2010 to August 2013

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026