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Sponsors and Collaborators: |
Sun Yat-sen University The Third Affiliated Hospital of Sun Yat-sen University |
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Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00818103 |
Compared with MS in white populations, in people of China descent multiple sclerosis (MS)is characterized by lower prevalence, more frequent and severe involvement of the visual system at onset and during the entire clinical course, more common occurrence of optic and spinal involvement, relatively rapid progression and less common occurrence of a progressive course. Data are not available for mainland China that are focused on characteristic studies of MS. In this study, the investigators sought to explore the characteristics of MS among Chinese in China, by conducting a study on genetics, pathogenesis, pathology, neuroimaging characteristics, and so on. Based on these data, the investigators try to explore the difference in neuromyelitis optical (NMO) and MS and provide clinical data for treatment guidelines for NNO and MS.
Condition | Intervention |
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Multiple Sclerosis |
Drug: atorvastatin Drug: β-interferon Drug: EPO |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Characteristic Study on Chinese Patients With Multiple Sclerosis |
Estimated Enrollment: | 600 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2016 |
Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Atorvastatin, β-interferon, EPO: Experimental |
Drug: atorvastatin
Atorvastatin 40mg p.o. qn for 2 years
Drug: β-interferon
β-interferon 50ug i.m. qod for 2 years
Drug: EPO
EPO 10000U i.h. bid for 5 days
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Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Criteria for neuromyelitis optical
At least two of three supportive criteria:
Criteria for multiple sclerosis:
Insidious neurological progression suggestive of MS, one year of disease progression (retrospectively or prospectively determined) and two of the following:
Exclusion Criteria:
Contact: Qiang Xue Hu, PhD | +862085252336 | huxueqiangzssy@yahoo.com.cn |
Contact: Qi Zheng Lu, PhD | +862085252336 | lzq1828@yahoo.com.cn |
China, Guangdong | |
Department of Neurology, The Third Affilated Hospital of Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510630 | |
Contact: Qiang Xue Hu, PhD +862085252336 huxueqiangzssy@yahoo.com.cn |
Responsible Party: | The Third Affiliated Hospital of Sun Yat-sen University, Department of Neurology ( Professor Hu Xueqiang ) |
Study ID Numbers: | 2007027, 2007027 |
Study First Received: | December 31, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00818103 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Multiple Sclerosis,Genetics,Pathogenesis,Pathology,Therapy |
Antimetabolites Autoimmune Diseases Demyelinating Diseases Antilipemic Agents Interferons Sclerosis Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Antiviral Agents Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Atorvastatin |
Antimetabolites Anti-Infective Agents Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Demyelinating Diseases Immune System Diseases Antineoplastic Agents Antilipemic Agents Nervous System Diseases Interferons Enzyme Inhibitors |
Sclerosis Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Antiviral Agents Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Atorvastatin |