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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02200718
Eligibility Criteria:
Inclusion Criteria:
* Ages Eligible for Study: 5 Years to 17 Years
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers: No Criteria
* Subject is between 5 and 17 years of age, inclusive
* Clinically diagnosed Pediatric MS
* Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a pediatric MS course
* Expanded Disability Status Scale (EDSS) \<= score 6.5 (Appendix B) Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 12 months prior to screening
* Laboratory values within the following limits:
* Creatinine 1 . 5 x high normal
* Hemoglobin
Exclusion Criteria:
* Subjects currently prescribed Campath or Lemtrada
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT02200718
Study Brief:
Protocol Section:
NCT02200718