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Famciclovir in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Famciclovir
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal London Hospital, Barts Health NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2022
Last Updated
March 7, 2022
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT05283551
Brief Title
Famciclovir in Multiple Sclerosis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
November 25, 2023 (Anticipated)
Study Completion Date
November 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Famciclovir
Intervention Description
Famciclovir (500mg BD)
Primary Outcome Measure Information:
Title
Effect of famciclovir on Epstein-Barr virus (EBV) shedding
Description
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
Other Pre-specified Outcome Measures:
Title
Explore the effect of famciclovir (500mg BD) on serological markers of Epstein-Barr virus (EBV) infection (anti-EBNA-1 and anti-VCA IgG)
Description
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
Title
Explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) viral replication in blood
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Dobson, MA MRCP PhD
Phone
0207 882 6463
Email
ruth.dobson@qmul.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Bianchi, PhD
Phone
020 3594 0637
Email
l.bianchi@qmul.ac.uk
Facility Information:
Facility Name
Royal London Hospital, Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Dobson, MA MRCP PhD
Phone
0207 882 6463
Email
ruth.dobson@qmul.ac.uk
First Name & Middle Initial & Last Name & Degree
Lucia Bianchi, PhD
Phone
020 3594 0637
Email
l.bianchi@qmul.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Famciclovir in Multiple Sclerosis

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