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

December 31, 2008
September 27, 2009
January 2006
January 2015   (final data collection date for primary outcome measure)
The recurrence of NMO or MS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00818103 on ClinicalTrials.gov Archive Site
EDSS scores, active lesion detected by MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Characteristic Study on Chinese Patients With Multiple Sclerosis
Characteristic Study on Chinese Patients With Multiple Sclerosis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Multiple Sclerosis
  • 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
Experimental: Atorvastatin, β-interferon, EPO
Interventions:
  • Drug: atorvastatin
  • Drug: β-interferon
  • Drug: EPO
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
January 2016
January 2015   (final data collection date for primary outcome measure)

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
Both
up to 65 Years
No
Contact: Qiang Xue Hu, PhD +862085252336 huxueqiangzssy@yahoo.com.cn
Contact: Qi Zheng Lu, PhD +862085252336 lzq1828@yahoo.com.cn
China
 
NCT00818103
2007027, 2007027
Not Provided
Professor Hu Xueqiang, The Third Affiliated Hospital of Sun Yat-sen University, Department of Neurology
Sun Yat-sen University
Third Affiliated Hospital, Sun Yat-Sen University
Not Provided
Sun Yat-sen University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP