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.
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 multiple-sclerosis
Started Nov 2020
Typical duration for phase_2 multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2020
CompletedFirst Submitted
Initial submission to the registry
February 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2023
CompletedMarch 17, 2022
February 1, 2022
3 years
February 24, 2022
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Explore the effect of famciclovir (500mg BD) on serological markers of Epstein-Barr virus (EBV) infection (anti-EBNA-1 and anti-VCA IgG)
Baseline to 36 Weeks
Explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) viral replication in blood
Baseline to 36 Weeks
Study Arms (1)
Single arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal London Hospital, Barts Health NHS Trust
London, E1 1BB, United Kingdom
Related Publications (1)
Dobson R, Holden D, Vickaryous N, Bestwick J, George K, Sayali T, Bianchi L, Wafa M, Gold J, Giovannoni G. A phase 2a open-label clinical trial to determine the effect of famciclovir on EBV activity as measured by EBV shedding in the saliva of patients with multiple sclerosis. Mult Scler. 2024 Jan;30(1):63-70. doi: 10.1177/13524585231215268. Epub 2023 Dec 22.
PMID: 38131621DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2022
First Posted
March 17, 2022
Study Start
November 25, 2020
Primary Completion
November 25, 2023
Study Completion
November 25, 2023
Last Updated
March 17, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share