Famciclovir in Multiple Sclerosis

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.

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Famciclovir

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ruth Dobson, MA MRCP PhD; Phone Number: 0207 882 6463; Email: ruth.dobson@qmul.ac.uk
• Study Contact Backup: Name: Lucia Bianchi, PhD; Phone Number: 020 3594 0637; Email: l.bianchi@qmul.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, E1 1BB
    • Recruiting
    • Royal London Hospital, Barts Health NHS Trust
    • Contact: Ruth Dobson, MA MRCP PhD; Phone Number: 0207 882 6463; Email: ruth.dobson@qmul.ac.uk
    • Contact: Lucia Bianchi, PhD; Phone Number: 020 3594 0637; Email: l.bianchi@qmul.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm	Drug: Famciclovir; Famciclovir (500mg BD)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore the effect of famciclovir (500mg BD) on serological markers of Epstein-Barr virus (EBV) infection (anti-EBNA-1 and anti-VCA IgG)	Level of serological markers of EBV infection (anti-EBNA-1 IgG and anti-VCA IgG) in particpants' blood in the IMP treatment phase (famciclovir 500mg BD) and post treatment phase of the Study compared with level of serological markers of EBV infection (anti-EBNA-1 IgG and anti-VCA IgG) in the pre-treatment phase of the Study	Baseline to 36 Weeks
Explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) viral replication in blood	Level of of EBV DNA in particpants' blood in the IMP treatment phase (famciclovir 500mg BD) and post treatment phase of the Study compared with level of EBV DNA in in the pre-treatment phase of the Study	Baseline to 36 Weeks

Collaborators and Investigators

• Sponsor: Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Anticipated): November 25, 2023
• Study Completion (Anticipated): November 25, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Famciclovir
• Other Study ID Numbers: 249627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No