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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02430532
Eligibility Criteria:
Key Inclusion Criteria:
* Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by relapses.
* Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization.
* Have an Expanded Disability Status Scale score of 3.0 to 6.5, inclusive.
* Have a Multiple Sclerosis (MS) Severity Score of 4 or higher.
Key Exclusion Criteria:
* Have a diagnosis of relapsing remitting multiple sclerosis or primary progressive MS as defined by the revised McDonald criteria.
* Had a recent clinical relapse (within 3 months) prior to randomization.
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
58 Years
Study:
NCT02430532
Study Brief:
Protocol Section:
NCT02430532