Multiple Sclerosis
Conditions
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
Interventions
DRUGFamciclovir
Famciclovir (500mg BD)
Sponsors
Queen Mary University of London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) viral replication in blood | Baseline to 36 Weeks | 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 |
Countries
United Kingdom
Contacts
Primary ContactRuth Dobson, MA MRCP PhD
Backup ContactLucia Bianchi, PhD
Outcome results
None listed