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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT01854359
Eligibility Criteria:
* INCLUSION CRITERIA:
* Completion of 3 years in study IPPoMS (Protocol Number 09-N-0197)
* Able to provide informed consent
* Adults, at least 18 years of age
* Willing to participate in all aspects of trial design and follow-up
* If able to become pregnant or to father a child, agreeing to commit to the use of a reliable/accepted method of birth control (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation, or vasectomy)) for the duration of treatment arm of the study
EXCLUSION CRITERIA:
* Pregnant or lactating women. All women of child-bearing potential must have a negative pregnancy test
* Patients dropping out of IPPoMS due to adverse events (AE) considered related to study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01854359
Study Brief:
Protocol Section:
NCT01854359