Two separate trials will test the experimental drug CK-2017357 and a surgical procedure called a thymectomy in people with MG
Two clinical trials — one of an experimental medication and the other of a surgical procedure — are available to people with myasthenia gravis (MG) who meet enrollment criteria.
The pharmaceutical company Cytokinetics, in conjunction with the National Institute of Neurological Disorders and Stroke (NINDS), is testing its experimental compound CK-2017357 against a placebo in a phase 2, multicenter trial slated to include 36 adults with MG.
Prospective participants must have evidence of muscle weakness; antibodies (immune system proteins) to the acetylcholine receptor, the part of the muscle fiber that receives signals from the nervous system; and meet other study criteria.
CK-2017357 is designed to increase the sensitivity of skeletal muscle fibers to calcium, possibly increasing muscle force and prolonging the time it takes for muscles to fatigue.
The investigators will be evaluating the effect of CK-2017357 on muscle strength, muscle fatigue and pulmonary function.
There are 16 study sites distributed across the United States.
To participate in the CK-2017357 study
For details and contact information, see Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis; or enter NCT01268280 into the search box at ClinicalTrials.gov.
The National Institute of Neurological Disorders and Stroke is funding a phase 3 trial of a surgical procedure known as a thymectomy — removal of the thymus — in an estimated 150 adults with myasthenia gravis (MG) at 50 sites throughout the United States and other countries.
Removal of the thymus, an organ located in the chest that plays a role in the immune system, has been used for many years as a treatment for MG, an autoimmune disease. However, conclusive data on its effectiveness are lacking.
This study seeks to gather data on whether thymectomy plus the steroid drug prednisone is more effective than prednisone alone, and whether the amount of prednisone required to control symptoms differs when a thymectomy has been performed.
Prospective participants must be 18 to 65 years old, meet diagnostic criteria for MG, have experienced onset of generalized MG within the last five years, not have a tumor in the thymus (thymoma) and meet other study criteria.
Study participants will be randomly assigned to receive treatment with prednisone alone or to receive prednisone plus a thymectomy. They'll be followed for at least three years.
To participate in the thymectomy study
For details and contact information, see Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy; or enter NCT00294658 into the search box at ClinicalTrials.gov.
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