Characteristic Study on Chinese Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Characteristic Study on Chinese Patients With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00818103
• Other study ID #: 2007027
• Secondary ID: 2007027
• Status: Recruiting
• Phase: N/A
• First received: December 31, 2008
• Last updated: September 27, 2009
• Start date: January 2006
• Est. completion date: January 2016

Study information

• Verified date: September 2009
• Source: Sun Yat-sen University
• Contact: Qiang Xue Hu, PhD
• Phone: +862085252336
• Email: huxueqiangzssy[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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, ß-interferon, EPO, immunoglobulin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• atorvastatin
Atorvastatin 40mg p.o. qn for 2 years
• ß-interferon
ß-interferon 50ug i.m. qod for 2 years
• EPO
EPO 10000U i.h. bid for 5 days

Locations

Country	Name	City	State
China	Department of Neurology, The Third Affilated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrence of NMO or MS		1 year	No
Secondary	EDSS scores, active lesion detected by MRI		1 year	No

External Links

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