Status:

UNKNOWN

Famciclovir in Multiple Sclerosis

Lead Sponsor:

Queen Mary University of London

Conditions:

Multiple Sclerosis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 participa...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 25 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 25 2023

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT05283551

Start Date

November 25 2020

End Date

November 25 2023

Last Update

March 17 2022

Active Locations (1)

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1

Royal London Hospital, Barts Health NHS Trust

London, United Kingdom, E1 1BB