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Characteristic Study on Chinese Patients With Multiple Sclerosis

This study is currently recruiting participants.
Verified September 2009 by Sun Yat-sen University
Sponsor:
Collaborator:
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00818103
First received: December 31, 2008
Last updated: September 27, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention
Multiple Sclerosis
 Drug: atorvastatin
Drug: β-interferon
Drug: EPO

Sun Yat-sen University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Characteristic Study on Chinese Patients With Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The recurrence of NMO or MS [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EDSS scores, active lesion detected by MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2006
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

      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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818103

Contacts
Contact: Qiang Xue Hu, PhD +862085252336 huxueqiangzssy@yahoo.com.cn
Contact: Qi Zheng Lu, PhD +862085252336 lzq1828@yahoo.com.cn

Locations
China, Guangdong
Department of Neurology, The Third Affilated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Qiang Xue Hu, PhD     +862085252336     huxueqiangzssy@yahoo.com.cn    
Sponsors and Collaborators
Sun Yat-sen University
Third Affiliated Hospital, Sun Yat-Sen University
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Professor Hu Xueqiang, The Third Affiliated Hospital of Sun Yat-sen University, Department of Neurology
ClinicalTrials.gov Identifier: NCT00818103     History of Changes
Other Study ID Numbers: 2007027, 2007027
Study First Received: December 31, 2008
Last Updated: September 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Multiple Sclerosis,Genetics,Pathogenesis,Pathology,Therapy

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferons
Atorvastatin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 18, 2013