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Myasthenia Gravis clinical trials

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NCT ID: NCT00997412 Active, not recruiting - Myasthenia Gravis Clinical Trials

Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis

Myfortic
Start date: May 2009
Phase: N/A
Study type: Interventional

This is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive drugs, in myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis (MG) patients who are poor controlled under prior steroid therapy. All subjects should be randomly assigned to MA group and AZA group that will receive routine pyridostigmine and prednisolone in combination with MA or AZA.

NCT ID: NCT00995722 Terminated - Clinical trials for Ocular Myasthenia Gravis

Efficacy of Prednisone In the Treatment of Ocular Myasthenia

EPITOME'
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and tolerability of prednisone in patients diagnosed with ocular myasthenia. Funding Source - FDA OOPD

NCT ID: NCT00987116 Completed - Myasthenia Gravis Clinical Trials

Study Comparing Two Tapering Strategies of Prednisone in Myasthenia Gravis

MYACOR
Start date: June 2009
Phase: Phase 4
Study type: Interventional

Pathology - Generalized myasthenia gravis (MG) is cause of muscle weakness that can have a significant impact on daily life activity but can also be, when respiratory or bulbar muscles are involved, life-threatening. Rationale - Additionally to thymectomy, which indication of is still debated in absence of thymoma, the long-term treatment of generalized myasthenia gravis includes usually prednisone and azathioprine. However, the most used scheme for prescribing and tapering corticosteroid in MG resulted in a very important cumulative dose of prednisone. Indeed, at twelve month, more than 50 percent of patients are still daily treated with at least 18 mg of prednisone and the proportion of patients who are in remission and no longer taking prednisone is very low (Palace and NEWSOM Davis, Neurology 1998). Prolonged corticosteroid therapy is accompanied with various and major side effects, hypertension, osteoporosis, weight gain, glaucoma. Therefore, tapering, eventually discontinuing, prednisone earlier is a relevant therapeutic goal. For this reason, the investigators will compare to the standard one, a strategy consisting of a rapid decrease in corticosteroid. Objective - To assess whether, in patients with generalized MG requiring a long-term treatment with corticosteroids and azathioprine, that the strategy of rapid tapering allows discontinuing more rapidly the prednisone for equivalent efficacy than the classical strategy.

NCT ID: NCT00814138 Completed - Myasthenia Gravis Clinical Trials

Efficacy of Methotrexate in Myasthenia Gravis

Start date: April 2009
Phase: Phase 2
Study type: Interventional

Myasthenia gravis is a rare neuromuscular disorder characterized by weakness and fatigability of ocular, bulbar, and extremity musculature. The specific aim of this study is to determine if oral methotrexate is an effective therapy for myasthenia gravis (MG) patients who are prednisone dependent. Patients will be randomized to receive either methotrexate or placebo and those who are entered onto this trial will have symptoms and signs of the disease while on prednisone therapy. The hypothesis is that adding methotrexate therapy in these patients will improve the MG manifestations so that the prednisone dose can be reduced and clinical measures of MG severity will improve. Funding Source - FDA OOPD

NCT ID: NCT00774462 Completed - Myasthenia Gravis Clinical Trials

Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia Gravis

FORCE
Start date: January 2008
Phase: Phase 2
Study type: Interventional

The traditional treatment of inflammatory myopathies (IM) and generalized myasthenia gravis (MG) is immunosuppressive therapy, usually beginning with corticosteroids. However, up to 70% of treated patients show an incomplete response, including 10 - 30% who are unresponsive. Corticosteroids and other immunosuppressive therapies presented also many side effects. We propose to evaluate in a pilot, open, prospective, multicentric, phase II study, the interest of rituximab in the treatment of patients with primary IM associated with specific AAb (anti-synthetase and anti-SRP AAbs), or MG (with anti-AchR AAbs), refractory to conventional therapies. Twenty fourth patients with primary IM (12 with anti-synthetase, 12 with anti-SRP AAbs), and 12 with MG will be included in the study.

NCT ID: NCT00727194 Terminated - Myasthenia Gravis Clinical Trials

Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

Start date: October 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.

NCT ID: NCT00716066 Active, not recruiting - Myasthenia Gravis Clinical Trials

Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases

Start date: June 2008
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well carmustine, etoposide, cytarabine and melphalan together with antithymocyte globulin before a stem cell transplant works in treating patients with autoimmune neurologic disease that did not respond to previous therapy. In autoimmune neurological diseases, the patient's own immune system 'attacks' the nervous system which might include the brain/spinal cord and/or the peripheral nerves. Giving high-dose chemotherapy, including carmustine, etoposide, cytarabine, melphalan, and antithymocyte globulin, before a stem cell transplant weakens the immune system and may help stop the immune system from 'attacking' a patient's nervous system. When the patient's own (autologous) stem cells are infused into the patient they help the bone marrow make red blood cells, white blood cells, and platelets so the blood counts can improve.

NCT ID: NCT00704626 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Serum Auto-Antibodies in Neurological Diseases

SAA
Start date: January 2002
Phase:
Study type: Observational

Under normal conditions our immune system protects us against infections and tumors. The immune system does this by recognizing that the infecting organism or the tumor is foreign to the body and attacking it. One way the immune system attacks a foreign target is by making proteins called antibodies that bind to the target. Sometimes, for reasons we poorly understand, the immune system wrongly identifies part of our own body as being foreign and attacks it. This can result in disease such as some forms of diabetes and thyroid disease, as well as some neurological diseases. In this study, one tablespoon of blood will be removed from each subject and tested to see if the immune system is making antibodies against components of the nerves and muscles. We also hope to learn if these antibodies contribute to the development or worsening of illnesses of the nervous system. Only one blood draw is required, but subjects may be asked to give up to 8 additional blood samples to see if the level of antibodies changes over time. Any additional blood draws would be performed at regularly scheduled clinic visits. There would be at least 3 months between blood draws over a period of up to 3 years, if requested by the physician. Depending on your diagnosis, the physician may also request the collection of mouth (buccal) cells. This takes about one minute and is painless. The cells are collected by swishing a swab around your mouth. This cheek swab would be done with each blood draw. Please note that this study is conducted ONLY at UC Davis and that all participants must be seen in our clinic located in Sacramento, CA. Results of the testing performed in this study are not given to the participants. This study is not intended to treat or diagnose any condition.

NCT ID: NCT00683969 Completed - Clinical trials for Myasthenia Gravis, Generalized

A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis

Start date: August 2004
Phase: Phase 3
Study type: Interventional

The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00619671 Completed - Clinical trials for Refractory Myasthenia Gravis

A Pilot Trial of Rituxan in Refractory Myasthenia Gravis

Start date: April 2004
Phase: Phase 1/Phase 2
Study type: Interventional

Myasthenia gravis is a disease that happens because the immune system attacks the nervous system. The damage is caused by antibodies produced by B lymphocytes. These antibodies damage a special part of the muscle that helps transmit impulses from nerves to muscles to allow muscles to work properly. This damage results in symptoms of myasthenia gravis. Participants are being asked to participate in this research study because their myasthenia gravis has either failed to respond to treatments commonly used in the disease, or they have had bad side-effects from such treatments. This is a research study of a drug called Rituximab. Rituximab, also called Rituxan, is a mouse antibody that has been changed to make it similar to a human antibody. Antibodies are proteins that can protect the body from foreign invaders, such as bacteria and viruses, by binding to substances called antigens. Rituxan works by binding to a protein, called the CD20 protein. Rituxan helps to destroy white blood cells that produce antibodies in the body, called B-lymphocytes. It is a treatment given through a vein in the participant's arm over a period of approximately 4-6 hours. It has been approved by the Food and Drug Administration (FDA) for use in patients with a form of cancer of the lymph glands called Non-Hodgkin's Lymphoma (NHL). Rituximab is not approved for their myasthenia gravis. Treatment with Rituximab is being tried in this research study because Rituximab decreases B lymphocytes. There is preliminary evidence that Rituximab helps some patients with chronic and otherwise difficult to treat myasthenia gravis.