Status:
UNKNOWN
Characteristic Study on Chinese Patients With Multiple Sclerosis
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
Up to 65 years
Phase:
NA
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 du...
Eligibility Criteria
Inclusion
- Criteria for neuromyelitis optical
- 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:
- Positive brain MRI (nine T2 lesions or four or more T2 lesions with positive VEP)
- Positive spinal cord MRI (two focal T2 lesions)
- Positive CSF
Exclusion
- \> 65 yrs old
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00818103
Start Date
January 1 2006
End Date
January 1 2016
Last Update
September 29 2009
Active Locations (1)
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1
Department of Neurology, The Third Affilated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630