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:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT02220933
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis criteria of secondary or primary progressive MS with clinical evidence of spastic paraparesis fulfilling revised McDonald criteria (2010) and Lublin criteria (1996)
* Progression of the EDSS during the past two years of at least 1 point if EDSS from 4.5 to 5.5 and at least 0.5 point if EDSS from 6 to 7
* EDSS score from 4.5 to 7 (measured away from a relapse and confirmed at 6 months)
* Informed consent prior to any study procedure
* Patient aged 18-75 years
Exclusion Criteria:
* Any general chronic handicapping disease other than MS
* Intensive physical therapy program within the 3 months prior to inclusion
* Impossibility to perform the TW25 test
* New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine
* Pregnancy or woman with childbearing potential without contraception
* Evidence of inflammatory activity of the disease defined as "clinical evidence of a relapse during the year before inclusion or evidence of new gadolinium-enhanced lesions on a brain MRI performed the year before inclusion."
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02220933
Study Brief:
Protocol Section:
NCT02220933