Characteristic Study on Chinese Patients With Multiple Sclerosis
NCT ID: NCT00818103
Last Updated: 2009-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2006-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Atorvastatin, β-interferon, EPO
atorvastatin
Atorvastatin 40mg p.o. qn for 2 years
β-interferon
β-interferon 50ug i.m. qod for 2 years
EPO
EPO 10000U i.h. bid for 5 days
Interventions
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atorvastatin
Atorvastatin 40mg p.o. qn for 2 years
β-interferon
β-interferon 50ug i.m. qod for 2 years
EPO
EPO 10000U i.h. bid for 5 days
Eligibility Criteria
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Inclusion Criteria
* Optic neuritis
* Acute myelitis
* At least two of three supportive criteria:
* Contiguous spinal cord MRI lesion extending over \>= 3 vertebral segments
* Brain MRI not meeting diagnostic criteria for multiple sclerosis
* NMO-IgG seropositive status
* Criteria for multiple sclerosis:
* Two or more attacks; objective clinical evidence of two or more lesions, OR
* Two or more attacks; objective clinical evidence of one lesion, dissemination in space, demonstrated by: MRI or two or more MRI-detected lesions consistent with MS plus positive CSF or wait further clinical attack implicating a different site, OR
* One attack; objective clinical evidence of two or more lesions, dissemination in time, demonstrated by: MRI or second clinical attack, OR
* One attack; objective clinical evidence of one lesion (monosymptomatic presentation; clinically isolated syndrome), dissemination in space, demonstrated by: MRI or two or more MRI-detected lesions consistent with MS plus positive CSF and dissemination in time, demonstrated by: MRI or second clinical attack, OR
* Insidious neurological progression suggestive of MS, one year of disease progression (retrospectively or prospectively determined) and two of the following:
1. Positive brain MRI (nine T2 lesions or four or more T2 lesions with positive VEP)
2. Positive spinal cord MRI (two focal T2 lesions)
3. Positive CSF
Exclusion Criteria
* Heavy damage of heart, lung, liver, renal function
* Late neuromyelitis optical or EDSS \> 6.0
* Serious hypertension and diabetes
* Serious mental disorders and depression
* Allergic to drug: atorvastatin, β-interferon, EPO, immunoglobulin
65 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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The Third Affiliated Hospital of Sun Yat-sen University, Department of Neurology
Locations
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Department of Neurology, The Third Affilated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Qiang Xue Hu, PhD
Role: primary
References
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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.
Related Links
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Other Identifiers
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2007027
Identifier Type: -
Identifier Source: secondary_id
2007027
Identifier Type: -
Identifier Source: org_study_id