Overview

Famciclovir in Multiple Sclerosis

Status:
Recruiting
Trial end date:
2023-11-25
Target enrollment:
0
Participant gender:
All
Summary
This is a proof-of-concept study in 30 patients with established Relapsing Remitting Multiple Sclerosis (RRMS). IMP is Famciclovir. It is a phase II type A open label study. Each individuals participation in the study will last 36 weeks and will be divided into three phases: pre-treatment (12 weeks), treatment with famciclovir (12 weeks), and post-treatment (12 weeks). During the first 12 week phase patients will remain on their usual treatment alone; this will be followed by three months of co-treatment with famciclovir and then followed by a final three months post-famciclovir treatment where participants will continue to take their usual treatment for RRMS. The primary aim is to explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) shedding in the saliva of patients with MS
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Queen Mary University of London
Treatments:
Famciclovir
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