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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT05283551
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with MS
* Males and females aged over 18
* Taking Natalizumab (Tysabri) for the treatment of MS,
* Be able to provide informed consent to take part in this study.
* Female patients of childbearing potential (defined in section 13.4) must be willing to follow protocol contraceptive requirements.
Exclusion Criteria:
* Taking MS disease modifying treatment other than natalizumab (Tysabri)
* On no treatment for MS
* Taking additional immunomodulatory agents (either for MS treatment or other reasons)
* Has received a course of high dose oral or intravenous steroids within 3 months of study entry. The use of low dose (total daily dose \<10mg) and/or the use of topical steroids will not act as an exclusion criteria.
* Taking antiviral or antiretroviral medication for any reason
* Known allergy to penciclovir, acyclovir, valaciclovir or famciclovir
* Taking probenecid
* Significant renal (CKD 3 or 4) and/or liver (ALT\>3x ULN) impairment
* Pregnant, or unwilling to take measures to prevent pregnancy
* Breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05283551
Study Brief:
Protocol Section:
NCT05283551