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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT02495766
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 and 60 years of age
* Patients with MS
* Relapsing-remitting or secondary progressive MS
* Patients to whom are not indicated or are not in a position to initiate treatment with disease-modifying drugs
* Expanded Disability Status Scale (EDDS) score \<6.5
* Nine T2 lesions at least
* Active multiple sclerosis as defined either by 1 outbreak in the last year or at least one Gadolinium-enhancing lesion in the last 6 months
* Signed informed consent form
Exclusion Criteria:
* Interferon beta or glatiramer acetate 3 months prior the screening
* Natalizumab or fingolimod in the 6 months prior the screening
* Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time
* Has received an experimental treatment within 3 months prior the screening
* MS outbreak within the 4 weeks prior the randomization
* Serum creatinine\> 2.0 mg/dl
* Infectious disease active or uncontrolled
* Fertile patients who are not using a suitable method of contraception
* Pregnant or lactating woman
* Immunodeficiency
* Positive serology to HIV, Hepatitis B, Hepatitis C or syphilis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02495766
Study Brief:
Protocol Section:
NCT02495766