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:
NCT02386566
Eligibility Criteria:
Key Inclusion Criteria:
* Subjects that have a confirmed diagnosis of RRMS, as per the 2010 revised McDonald criteria
* Subjects satisfying the therapeutic indication of natalizumab, as described in the local product label and confirmed by the Investigator. (Patients with previous treatment with natalizumab are also considered to be eligible only if the last natalizumab infusion was at least 1 year before the screening visit of this study)
* Decision for a treatment with natalizumab has been made before screening
* Patients with an EDSS score of 2.0-5.5 (both limits inclusive)
Key Exclusion Criteria:
* Patients with a diagnosed co-existing brain pathology other than MS, which in the judgement of the investigator impacts the value of EDSS or QoL.
* Pure spinal manifestation of demyelination
* Diagnosis of primary or secondary progressive MS
* Any change in concomitant medication known to affect cognition or bladder function
* A history of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse, as assessed by the Investigator
NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02386566
Study Brief:
Protocol Section:
NCT02386566