Famciclovir in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-25

Study Completion Date

2023-11-25

Brief Summary

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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

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

Famciclovir

Intervention Type DRUG

Famciclovir (500mg BD)

Interventions

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Famciclovir

Famciclovir (500mg BD)

Intervention Type DRUG

Eligibility Criteria

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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)
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No