Study of Pioglitazone in Sporadic Inclusion Body Myositis (NCT03440034) | Clinical Trial Compass
CompletedPhase 1
Study of Pioglitazone in Sporadic Inclusion Body Myositis
United States19 participantsStarted 2018-05-22
Plain-language summary
A study looking at the effect of pioglitazone in skeletal muscle of patients with sporadic inclusion body myositis (sIBM).
Who can participate
Age range50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 50 years
* Diagnosis of sporadic inclusion body myositis (sIBM) based on the sIBM Diagnostic Criteria established by the 2010 European Neuromuscular Center.
* Must be able to ambulate at least 20 feet, with or without the use of an assistive device. Patients may not use another person, wall, or furniture for support.
* Must be able to rise from a chair without support from another person or device.
* Premenopausal women must have a negative serum pregnancy test prior to dosing with study medication.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
Exclusion Criteria:
* A history of diabetes mellitus, or prior or concurrent treatment with any diabetes therapy
* Use of chronic immunosuppressive therapy including corticosteroids or intravenous immune globulin (IVIG) within the past 6 months.
* Use of Vitamin E supplements within the past 3 months
* Creatine kinase (CK) \> 15x the upper limit of normal
* Any condition other than sIBM that causes significant muscle pain, muscle weakness, muscle atrophy, or joint pain. This includes but is not limited to such neurologic and neuromuscular diseases as polymyositis or dermatomyositis, myasthenia gravis, amyotrophic lateral sclerosis, stroke, multiple sclerosis, epilepsy, muscular dystrophy, fibromyalgia, rheumatoid arthritis, spinal cord injury or …
What they're measuring
1
Change from baseline in Peroxisome proliferator-activated receptor gamma coactivator 1-alpha target gene expression
Timeframe: 4 weeks, 16 weeks, 32 weeks after baseline