Characteristic Study on Chinese Patients With Multiple Sclerosis

Study Overview
=================
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.

Official Title
-----------------
Characteristic Study on Chinese Patients With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: atorvastatin
* Drug: β-interferon
* Drug: EPO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: > 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

Ages Eligible for Study
-----------------
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin, β-interferon, EPO<br> | Drug: atorvastatin<br>* Atorvastatin 40mg p.o. qn for 2 years<br>Drug: β-interferon<br>* β-interferon 50ug i.m. qod for 2 years<br>Drug: EPO<br>* EPO 10000U i.h. bid for 5 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence of NMO or MS |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EDSS scores, active lesion detected by MRI |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis,Genetics,Pathogenesis,Pathology,Therapy