A Phase 2 interventional study of Famciclovir in Multiple Sclerosis, sponsored by Queen Mary University of London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by Queen Mary University of London · Phase 2, Interventional, and Health services research
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
3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Queen Mary University of London is the lead sponsor of 253 studies on the registry; 59 are open to participants now.
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Drug: Famciclovir
Famciclovir (500mg BD)
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.
Time frame: Baseline to 36 Weeks
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
Time frame: 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
Time frame: Baseline to 36 Weeks
Plan to share: No
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Famciclovir
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