Status unknownPhase 2MS (type not specified)NCT05283551

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Famciclovir

    Human herpesvirus 1 DNA polymerase inhibitor

What it measured

Main measures

  • Effect of famciclovir on Epstein-Barr virus (EBV) shedding

    Baseline to 36 Weeks

    Immune response

Who could take part

MS (type not specified) · 18 and over

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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Related trials

History

    1. Started

      Nov 2020

    2. Main results due

      Nov 2023

    3. Finished

      Nov 2023

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