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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT01142518
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a clinically demonstrated diagnosis of MS and present relapses
* Subjects who were relapse-free for the past 6 months with an Expanded Disability Status Scale (EDSS) range between 2 and 6
* Subjects who had a stable disease status during the past few months
* The last administration of mitoxantrone had been more than 3 months previously. In addition, the mitoxantrone treatment was given for at least a 12-month period, but for not more than 24 months, within a total dosage of 60-120 mg/m2 body surface area
Exclusion Criteria:
* Subjects with MS with secondary progression (SPMS) without relapse activity, pregnant or breast-feeding patients, as well as subjects with contraindications
* Subjects with existing systemic concomitant diseases (e.g. diabetes, heart, liver or kidney diseases)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01142518
Study Brief:
Protocol Section:
NCT01142518