Characteristic Study on Chinese Patients With Multiple Sclerosis - Full Text View

Sponsors and Collaborators:	Sun Yat-sen University The Third Affiliated Hospital of Sun Yat-sen University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00818103

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

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Atorvastatin Atorvastatin calcium Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Characteristic Study on Chinese Patients With Multiple Sclerosis

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
Atorvastatin, β-interferon, EPO: Experimental	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

The Third Affiliated Hospital of Sun Yat-sen University

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Responsible Party:	The Third Affiliated Hospital of Sun Yat-sen University, Department of Neurology ( Professor Hu Xueqiang )
Study ID Numbers:	2007027, 2007027
Study First Received:	December 31, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00818103
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sun Yat-sen University:

Multiple Sclerosis,Genetics,Pathogenesis,Pathology,Therapy

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Atorvastatin
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antilipemic Agents
Nervous System Diseases

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antiviral Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009