Famciclovir in Multiple Sclerosis

Study Overview
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Brief Summary
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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

Official Title
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A Phase 2 Open Label Clinical Trial to Determine the Effect of Famciclovir on Epstein-Barr Virus Activity as Measured by EBV Shedding in Saliva of Patients With Multiple Sclerosis.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Famciclovir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Drug: Famciclovir<br>* Famciclovir (500mg BD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of famciclovir on Epstein-Barr virus (EBV) shedding | 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. | Baseline to 36 Weeks |