Famciclovir in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283551
• Other study ID #: 249627
• Status: Recruiting
• Phase: Phase 2
• Start date: November 25, 2020
• Est. completion date: November 25, 2023

Study information

• Verified date: February 2022
• Source: Queen Mary University of London
• Contact: Ruth Dobson, MA MRCP PhD
• Phone: 0207 882 6463
• Email: ruth.dobson[@]qmul.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Famciclovir
Famciclovir (500mg BD)

Locations

Country	Name	City	State
United Kingdom	Royal London Hospital, Barts Health NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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