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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00595920
Eligibility Criteria:
Inclusion Criteria:
* Subjects who completed the TERMS study and received at least 1 study treatment injection
* Signed and dated statement of informed consent
Exclusion Criteria:
* Pregnancy or breastfeeding
* Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin in the TERMS study.
* Withdrew from TERMS study and did not continue participating in the remaining 52-week core TERMS study assessments.
* Non-compliant with TERMS study.
* Diagnosis of progressive-relapsing, secondary progressive or primary progressive Multiple Sclerosis (MS) while enrolled in the TERMS study.
* Medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study.
* Any significant change in the subject's medical condition after enrollment in the TERMS study which would have lead to his/her exclusion from participation in that study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00595920
Study Brief:
Protocol Section:
NCT00595920