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NCT00001421 · ClinicalTrials.gov registry record · Phase 2
Methimazole to Treat Polymyositis and Dermatomyositis
A Phase 2 study of Dermatomyositis and Polymyositis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00001421 is a Phase 2 study of Dermatomyositis and Polymyositis that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 20 participants, below the 484-participant average among 19 other Dermatomyositis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001421, a Phase 2 study of Dermatomyositis and Polymyositis, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 wil
Conditions Studied
Interventions
- DRUG methimazole
Study Locations (1)
Maryland
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 1995-06 |
| Est. Completion | 2001-04 |
| Phase | Phase 2 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001421
The ClinicalTrials.gov registry entry for NCT00001421 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 19 other Dermatomyositis trials with a reported enrollment target (96% lower). The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Dermatomyositis appearing as the primary indexed condition, and to 1 intervention - of which methimazole is the first listed.
NCT00001421 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001421 about?
NCT00001421 is a clinical study titled "Methimazole to Treat Polymyositis and Dermatomyositis". 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 ...
What is the current status of trial NCT00001421?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 1995-06. Estimated completion is 2001-04.
What conditions does trial NCT00001421 study?
This clinical trial studies the following conditions: Dermatomyositis, Polymyositis.
What interventions are being tested in trial NCT00001421?
The interventions under investigation include: methimazole (DRUG).
Who is sponsoring clinical trial NCT00001421?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001421 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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