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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT05172466
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis: RRMS (relapsing-remitting MS) or Multiple Sclerosis (Clinically Isolated Syndrome \[CIS\], Primary Progressive \[PPMS\], Secondary Progressive \[SPMS)
* Prescribed Tysabri (Natalizumab) or any other MS medication
* Natalizumab/Tysabri-naïve
* Ages 18-60
* Access to a smartphone\* \*In case a participant is ineligible due to lack of access to the technology, the study team will loan a tablet to participants for the duration of the study, free of charge. Participants will not be responsible for losing or damaging the device.
Exclusion Criteria:
* Inability to perform 5 or more of the BeCare App tasks independently
* EDSS \>6.5
* Corrective Visual Acuity lower than 20/200
* Any chronic illness that has not been stable for at least six months (medication changes during the past year for that condition are not exclusionary)
* Malignancy/previous chemotherapy treatment for neoplastic disease
* Untreated or unstable major depression or bipolar disease
* Clinical diagnosis: SPMS (Secondary-progressive multiple sclerosis) or PPMS (primary-progressive MS) 8. Acute COVID-19 infection with persisting symptoms for the last 6 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05172466
Study Brief:
Protocol Section:
NCT05172466