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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT01414634
Eligibility Criteria:
Inclusion Criteria:
1. Between the ages of 18 and 55 years.
2. Patients with relapsing-remitting (Phase I/II) or secondary progressive MS (Phase I) according to published criteria
3. EDSS score between 1 and 5.5.
4. Patients are off-treatment for standard therapies (interferon-beta, glatiramer acetate, natalizumab, mitoxantrone)
5. Patients are able to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.
6. Disease duration ≤ 5 years (Only Phase II)
Exclusion Criteria:
1. Diagnosis of secondary-progressive (Phase II) or primary-progressive MS, as defined by published diagnostic criteria.
2. Abnormal screening/baseline blood tests exceeding any of the limits defined
3. Pregnant or breast-feeding female.
4. History or signs of immunodeficiency.
5. Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease.
6. Splenectomy
7. History of HIV or positive HIV antibody testing
8. Serology indicating active Hepatitis B or C infection.
9. Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01414634
Study Brief:
Protocol Section:
NCT01414634