Methimazole to Treat Polymyositis and Dermatomyositis
Status:
Completed
Trial end date:
2001-04-01
Target enrollment:
Participant gender:
Summary
This study will test the safety and effectiveness of the drug methimazole in treating
polymyositis and dermatomyositis-inflammatory muscle diseases causing weakness and muscle
wasting. Although it is not known what causes of these diseases, abnormal immune function is
thought to be involved. Recent studies indicate that methimazole, which has been used for
many years to treat thyroid disease, may alter immune activity by affecting the interaction
between white blood cells called lymphocytes and certain molecules on cell surfaces. This
study will examine the effects of methimazole on immune activity and muscle strength in
patients with inflammatory muscle diseases and evaluate the drug side effects.
Patients with polymyositis and dermatomyositis who have normal thyroid function may be
eligible for this study [age requirement?]. Candidates will undergo a history and physical
examination; blood and urine tests; chest X-ray; muscle strength testing, daily living skills
questionnaire, and speech and swallowing evaluation; magnetic resonance imaging of muscles;
and muscle biopsy (removal of a small piece of muscle tissue under local anesthetic). When
indicated, some candidates may also have cancer screening tests (for example, mammogram, Pap
smear), a lung function test to measure breathing capacity, or an electromyogram, in which
small needles are inserted into a muscle to measure the electrical activity .
Participants will take 30 mg of methimazole by mouth twice a day for 6 months. They will have
blood tests weekly for the first 2 weeks and then every other week for the rest of the study
to measure blood counts and liver and thyroid function. Blood will also be drawn for white
blood cell studies during the screening evaluation, at the beginning of therapy, 6 to 12
weeks after therapy starts, at the end of the 6-month treatment period, and 1 and 3 months
after therapy ends. Muscle enzyme and urine tests will be done once a month.. During drug
treatment, patients will have periodic physical examinations and blood and muscle function
tests to evaluate the response to therapy.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)