Characteristic Study on Chinese Patients With Multiple Sclerosis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 31, 2008

Last Updated Date

January 5, 2009

Start Date ^†

January 2006

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00818103 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Characteristic Study on Chinese Patients With Multiple Sclerosis

Official Title ^†

Characteristic Study on Chinese Patients With Multiple Sclerosis

Brief 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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^†

Multiple Sclerosis

Intervention ^†

Drug: atorvastatin
Drug: β-interferon
Drug: EPO

Study Arms / Comparison Groups

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

600

Estimated Completion Date

January 2016

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

up to 65 Years

Accepts Healthy Volunteers

Contacts ^††

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

Location Countries ^†

China

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00818103

Responsible Party

Professor Hu Xueqiang, The Third Affiliated Hospital of Sun Yat-sen University, Department of Neurology

Secondary IDs ^††

2007027

Study Sponsor ^†

Sun Yat-sen University

Collaborators ^††

The Third Affiliated Hospital of Sun Yat-sen University

Investigators ^†

Information Provided By

Sun Yat-sen University

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.