Characteristic Study on Chinese Patients With Multiple Sclerosis
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 31, 2008 | ||||||||
| Last Updated Date | September 27, 2009 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The recurrence of NMO or MS [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00818103 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
EDSS scores, active lesion detected by MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Characteristic Study on Chinese Patients With Multiple Sclerosis | ||||||||
| Official Title ICMJE | Characteristic Study on Chinese Patients With Multiple Sclerosis | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label |
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| Condition ICMJE | Multiple Sclerosis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Experimental: Atorvastatin, β-interferon, EPO
Interventions:
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| Publications * | Zhang B, Jiang Y, Yang Y, Peng F, Hu X. Correlation between serum thyroxine and complements in patients with multiple sclerosis and neuromyelitis optica. Neuro Endocrinol Lett. 2008 Apr;29(2):256-60. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 600 | ||||||||
| Estimated Completion Date | January 2016 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00818103 | ||||||||
| Other Study ID Numbers ICMJE | 2007027, 2007027 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Professor Hu Xueqiang, The Third Affiliated Hospital of Sun Yat-sen University, Department of Neurology | ||||||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||||||
| Collaborators ICMJE | Third Affiliated Hospital, Sun Yat-Sen University | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Sun Yat-sen University | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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