Characteristic Study on Chinese Patients With Multiple Sclerosis

September 27, 2009 updated by: Sun Yat-sen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Department of Neurology, The Third Affilated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

      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:

  • > 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atorvastatin, β-interferon, EPO
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The recurrence of NMO or MS
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
EDSS scores, active lesion detected by MRI
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

December 31, 2008

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

September 29, 2009

Last Update Submitted That Met QC Criteria

September 27, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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