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 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT01721161
Eligibility Criteria:
Key Inclusion Criteria:
* Ability to provide written consent and any authorization required by law.
* Confirmed diagnosis of AON
* All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment.
Key Exclusion Criteria:
* Prior episode(s) of optic neuritis or loss of vision not due to AON.
* Subjects with an established diagnosis of multiple sclerosis are excluded except if newly diagnosed based on the current episode of AON and positive brain magnetic resonance imaging results consistent with the 2010 revisions to the McDonald's criteria.
* Previous history of a clinically significant disease.
* Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study.
* History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus.
* History or evidence of drug or alcohol abuse within 2 years prior to Screening.
* Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01721161
Study Brief:
Protocol Section:
NCT01721161