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Generated: February 18, 2019

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CLINICAL TRIALS PROFILE FOR METHIMAZOLE

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Clinical Trials for Methimazole

Trial ID Title Status Sponsor Phase Summary
NCT00001421 Methimazole to Treat Polymyositis and Dermatomyositis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 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.
NCT00150111 Rituximab in the Treatment of Graves' Disease Completed Odense University Hospital Phase 1/Phase 2 Aim: In a phase II pilot study encompassing 20 patients with Graves’ disease to evaluate the effect of rituximab: 1. Biochemically as assessed by markers of disease activity ( free T4, free T3, TSH, TSH-receptor antibodies, anti-TPO)
NCT00150124 Block-replacement Therapy During Radioiodine Therapy Completed Steen Bonnema Phase 4 Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves' disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced 'thyroid storm', which, however, is rarely encountered. Several studies have consistently shown that patients who are treated with ATD prior to 131I therapy have an increased risk of treatment failure. Mostly, patients with Graves' disease have been studied, while other studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD have 'radioprotective' properties, although this view is almost exclusively based on retrospective data and is still under debate. Indeed, this dogma was recently challenged by two randomized trials in Graves' disease, none of which showed such an adverse effect of methimazole pretreatment. It cannot be excluded that the earlier results may have been under influence of selection bias, a source of error almost unavoidable in retrospective studies. Whether ATD is radioprotective also when used in the post 131I period has also been debated. In the early period 131I therapy following a transient rise in the thyroid hormones is seen which may give rise to discomfort in some patients. The continuous use of ATD during 131I therapy, possibly in combination with levothyroxine (BRT: block-replacement therapy), leads to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy, euthyroidism can usually be maintained until the destructive effect of 131I ensues. Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the evidence is based on retrospective studies and the ideal set-up should be reconsidered. To underscore the importance of performing randomized trials we showed recently that resumption of methimazole seven days after 131I therapy had no influence on the final outcome. Aim:To clarify by a randomized trial whether BRT during radioiodine therapy of hyperthyroid patients influences the final outcome of this therapy, in a comparison with a regime in which methimazole as mono-therapy is discontinued 8 days before radioiodine. Patients and Methods: Consecutive patients suffering from recurrent Graves' disease (n=50) or a toxic nodular goiter (n=50) are included. All patients are rendered euthyroid by methimazole (MMI) and randomized either to stop MMI eight days before 131I or to be set on BRT. This latter medication continues until three months after 131I. Calculation of the 131I activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume. Patients are followed for one year with close monitoring of the thyroid function.
NCT00150137 Antithyroid Drugs During Radioiodine Therapy Completed Odense University Hospital Phase 4 Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves’ disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced ‘thyroid storm’, which, however, is rarely encountered. Several studies have consistently shown that patients who are treated with ATD prior to 131I therapy have an increased risk of treatment failure. Mostly, patients with Graves’ disease have been studied, while other studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD have ‘radioprotective’ properties, although this view is almost exclusively based on retrospective data and is still under debate (13). Indeed, this dogma was recently challenged by two randomized trials in Graves’ disease, none of which showed such an adverse effect of methimazole pretreatment. It cannot be excluded that the earlier results may have been under influence of selection bias, a source of error almost unavoidable in retrospective studies. Whether ATD is radioprotective also when used in the post 131I period has also been debated. In the early period 131I therapy following a transient rise in the thyroid hormones is seen which may give rise to discomfort in some patients. The continuous use of ATD during 131I therapy leads to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy, euthyroidism can usually be maintained until the destructive effect of 131I ensues. Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the evidence is based on retrospective studies and the ideal set-up should be reconsidered. To underscore the importance of performing randomized trials we showed recently that resumption of methimazole seven days after 131I therapy had no influence on the final outcome. Aim: To clarify by a randomized trial whether continuous use of methimazole during radioiodine therapy influences the final outcome of this therapy, in a comparison with a regime in which methimazole as mono-therapy is discontinued 8 days before radioiodine. Patients and Methods: 80 consecutive patients suffering from recurrent Graves’ disease or a toxic nodular goiter are included. All patients are rendered euthyroid by methimazole (MMI) and randomized either to stop MMI eight days before 131I or to continue MMI until four weeks after 131I. Calculation of the 131I activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume. Patients are followed for one year with close monitoring of the thyroid function.
NCT00677469 Low Doses of Cholestyramine in the Treatment of Hyperthyroidism Completed Shiraz University of Medical Sciences N/A The enterohepatic circulation of thyroid hormones is increased in thyrotoxicosis.Bile-salt sequestrants (ionic exchange resins) bind thyroid hormones in the intestine and thereby increase their fecal excretion. Based on these observations, the use of cholestyramine has been tried. The present study evaluates the effect of low doses of cholestyramine as an adjunctive therapy in the management of hyperthyroidism
NCT00725946 Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT Terminated Stanford University Early Phase 1 This is a pilot imaging study for women whose tumors express NIS [Na+I- symporter, sodium iodide symporter]. Eligibility is limited to the presence of strong (3+) and/or plasma membrane staining in > 20% of cells as determined by immunohistochemical methods. A total of 10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and methimazole (impedes organification). Tumor, organ and whole body dosimetry will be calculated in each patient.
NCT01458600 Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study) Completed Mikael Lantz Phase 4 AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms and eye protrusion. Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of ophthalmopathy. Specific aims: 1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months treatment with or without diclofenac. 2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy after 12 months treatment with or without diclofenac. 3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months treatment with or without diclofenac. Study plan and randomisation - 150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18 months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12 months.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Methimazole

Condition Name

Condition Name for Methimazole
Intervention Trials
Graves Disease 4
Graves' Disease 3
Graves´ Disease 2
Toxic Nodular Goitre 2
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Condition MeSH

Condition MeSH for Methimazole
Intervention Trials
Graves Disease 9
Hyperthyroidism 5
Graves Ophthalmopathy 3
Eye Diseases 3
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Clinical Trial Locations for Methimazole

Trials by Country

Trials by Country for Methimazole
Location Trials
Denmark 4
Malaysia 3
Iran, Islamic Republic of 2
United States 2
Brazil 1
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Trials by US State

Trials by US State for Methimazole
Location Trials
California 1
Maryland 1
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Clinical Trial Progress for Methimazole

Clinical Trial Phase

Clinical Trial Phase for Methimazole
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Methimazole
Clinical Trial Phase Trials
Completed 9
Terminated 2
Suspended 1
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Clinical Trial Sponsors for Methimazole

Sponsor Name

Sponsor Name for Methimazole
Sponsor Trials
Odense University Hospital 2
Stanford University 1
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 1
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Sponsor Type

Sponsor Type for Methimazole
Sponsor Trials
Other 15
Industry 1
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Baxter
US Army
Dow
Chinese Patent Office
Cipla
Merck
Covington
Accenture

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