NCT00818103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

September 29, 2009

Status Verified

September 1, 2009

Enrollment Period

9 years

First QC Date

December 31, 2008

Last Update Submit

September 27, 2009

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis,Genetics,Pathogenesis,Pathology,Therapy

Outcome Measures

Primary Outcomes (1)

  • The recurrence of NMO or MS

    1 year

Secondary Outcomes (1)

  • EDSS scores, active lesion detected by MRI

    1 year

Study Arms (1)

Atorvastatin, β-interferon, EPO

EXPERIMENTAL
Drug: atorvastatinDrug: β-interferonDrug: EPO

Interventions

atorvastatinDRUG

Atorvastatin 40mg p.o. qn for 2 years

Atorvastatin, β-interferon, EPO
β-interferonDRUG

β-interferon 50ug i.m. qod for 2 years

Atorvastatin, β-interferon, EPO
EPODRUG

EPO 10000U i.h. bid for 5 days

Atorvastatin, β-interferon, EPO

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Positive brain MRI (nine T2 lesions or four or more T2 lesions with positive VEP)
  • Positive spinal cord MRI (two focal T2 lesions)
  • +1 more criteria

You may not qualify if:

  • \> 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, The Third Affilated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related 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.

    PMID: 18404143RESULT

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Central Study Contacts

Qiang Xue Hu, PhD

CONTACT

+862085252336huxueqiangzssy@yahoo.com.cn

Qi Zheng Lu, PhD

CONTACT

+862085252336lzq1828@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Expanded Access
Yes

Study Record Dates

First Submitted

December 31, 2008

First Posted

January 7, 2009

Study Start

January 1, 2006

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

September 29, 2009

Record last verified: 2009-09

Locations

CN(1)