Famciclovir in Multiple Sclerosis
- Registration Number
- NCT05283551
- Lead Sponsor
- Queen Mary University of London
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm Famciclovir -
- Primary Outcome Measures
Name Time Method Effect of famciclovir on Epstein-Barr virus (EBV) shedding Baseline to 36 Weeks The primary outcome of this study is quantification of Epstein-Barr virus (EBV) shedding in saliva in the IMP treatment phase (famciclovir 500mg BD) and post treatment phase of the Study compared with Epstein-Barr virus (EBV) shedding in saliva in the pre-treatment phase of the Study Shedding is defined as EBV DNA levels in saliva \>5.8 copies/ml.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Royal London Hospital, Barts Health NHS Trust
🇬🇧London, United Kingdom