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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03326505
Eligibility Criteria:
Inclusion Criteria:
* A clinical diagnosis of definite MS according to the revised McDonald Criteria.
* Expanded Disability Status Scale (EDSS) ≤ 7
* Failure of standard medical therapy
* Disease duration of at least three years prior to enrollment.
Exclusion Criteria:
* Pregnant and lactating women
* Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
* Recent MS relapse in the month prior to enrollment
* Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
* Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
* Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
* Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
* Positive serology for HIV, Hepatitis B or Hepatitis C
* Any history of malignancy or exposure to radiation at any time prior to enrollment
* Any contra-indication to lumbar puncture
* Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03326505
Study Brief:
Protocol Section:
NCT03326505