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 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT02398461
Eligibility Criteria:
Inclusion Criteria:
* Males or females (18-70 years of age; \< 104 kg)
* Capable of giving informed consent
* Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
* Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
* Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.
Exclusion Criteria:
* Certain specified co-morbidities (including pregnancy)
* Taking certain proscribed medications
* A medical regimen that has changed in the month prior to screening
* Inability to undergo requisite MRI evaluations
* Drug or alcohol abuse
* Any other reason for which, in the opinion of the Investigator, the subject should not participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02398461
Study Brief:
Protocol Section:
NCT02398461