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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT02549703
Eligibility Criteria:
Inclusion criteria:
* male and female subjects age 18 or older
* diagnosis of one of the following:
1. RRMS according to McDonald 2010 criteria or a diagnosis of CIS with clinical symptoms and MRI consistent with MS
2. PPMS according to McDonald 2010 criteria
3. SPMS defined as at least six months of progressive decline following an initial relapsing disease course
* able and willing to undergo clinical evaluation, MRI, lumbar puncture, and skin biopsy and to return for follow up assessments at the end of year 1 and year 2
* able and willing to provide informed consent.
Exclusion criteria:
* pregnancy
* inability to undergo lumbar puncture, due to anticoagulant therapy that cannot be held for the day of the procedure or results of screening laboratory testing or the presence of another medical condition that would render the procedure unsafe, as determined by the investigator
* inability to undergo MRI, due to the presence of metallic implants incompatible with MRI or any other reason
* presence of other severe medical conditions likely to influence study results or that raise the likelihood of harm to the patient as a result of study participation, as determined by the investigator (e.g. the presence of a brain mass, which could influence the CSF results and also might make lumbar puncture unsafe)
* inability to complete the protocol for any reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02549703
Study Brief:
Protocol Section:
NCT02549703