Multiple SclerosisNCT00818103
Characteristic Study on Chinese Patients With Multiple Sclerosis
A study testing atorvastatin, β-interferon and EPO in people with Multiple Sclerosis, run by Sun Yat-sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- atorvastatin, β-interferon and EPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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)
- Positive CSF
Who cannot join
- > 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, The Third Affilated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Qiang Xue Hu, PhD, +862085252336, huxueqiangzssy@yahoo.com.cn
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- atorvastatin, β-interferon, EPO
- Keywords
- Multiple Sclerosis,Genetics,Pathogenesis,Pathology,Therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Atorvastatin 40mg p.o. qn for 2 years
β-interferonDrug
β-interferon 50ug i.m. qod for 2 years
EPODrug
EPO 10000U i.h. bid for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin, β-interferon, EPO | Experimental | Not described Receives: Drug: atorvastatin; Drug: β-interferon; Drug: EPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence of NMO or MS
Measured: 1 year
Secondary outcomes (1)
EDSS scores, active lesion detected by MRI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJan 2006
- Primary completionJan 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818103
- Sponsor's protocol ID
- 2007027
- Other IDs
- 2007027
- Status last verified
- Sep 2009
- First submitted
- 31 Dec 2008
- Last updated
- 29 Sep 2009
- Results posted
- No
- Expanded access
- Available
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.
PubMed 18404143
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristic Study on Chinese Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00818103
- Acronym / sponsor ID
- 2007027
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis,Genetics,Pathogenesis,Pathology,Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- Jan 2006
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin, β-interferon, EPO | Experimental | Drug: atorvastatin, Drug: β-interferon, Drug: EPO |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Criteria for neuromyelitis optical
- At least two of three supportive criteria:
- Criteria for multiple sclerosis:
Key exclusion criteria (6 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatinAtorvastatin 40mg p.o. qn for 2 years | Drug | Atorvastatin, β-interferon, EPO |
| β-interferonβ-interferon 50ug i.m. qod for 2 years | Drug | Atorvastatin, β-interferon, EPO |
| EPOEPO 10000U i.h. bid for 5 days | Drug | Atorvastatin, β-interferon, EPO |
Primary outcome
The recurrence of NMO or MS
Time frame: 1 year
1 secondary outcome
EDSS scores, active lesion detected by MRI
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2009.
- Results publication: PubMed 18404143Zhang 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin, β-interferon and EPO in people with Multiple Sclerosis, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Xue Hu, PhD (+862085252336, huxueqiangzssy@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence of NMO or MS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00818103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2009; AzTrials last refreshed its copy on 1 Nov 2026.