Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT00818103
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
65 Years
Study:
NCT00818103
Study Brief:
Protocol Section:
NCT00818103