Type of study: Interventional trial
Coordinating investigator: Gro Owren Nygaard (OUS)
Background/Rationale: Multiple sclerosis (MS) is an immune-mediated, inflammatory disease of the central nervous system (CNS), caused by a complex interplay between genes and environmental factors. Our research group have recently presented novel insights indicating that infection with the Epstein-Barr Virus (EBV) is the leading cause of MS. Since EBV infection is persistent for life, it is speculated if the virus could act as a trigger or driver of MS-disease activity. Evidence supports that antiviral therapy could be beneficial in MS, further supported by recent case reports describing that Tenofovir alafenamide fumarate (TAF) may stabilize the MS disease course. On this background, we have established an EU-funded consortium with partners from Oslo, Stockholm, Brussels, Barcelona, Rome, and Boston to study possible pathogenetic mechanisms of EBV in MS. Neuro-SysMed at University of Bergen and Haukeland University Hospital will coordinate project and be responsible for two clinical trials: The second trial is the tenofovir alafenamide fumarate (TAF)2-MS. This is a phase 2 clinical study aiming to determine whether TAF can influence MS disease activity in RRMS. (See TAF-MS 1 here.)
The objective of this study is to investigate the efficacy and safety of tenofovir alafenamide (TAF) on disease activity in patients with relapsing-remitting MS (RRMS).
Design: This is a randomised double-blinded, placebo-controlled trial comparing the efficacy and safety and of tenofovir alafenamide fumarate (TAF) 25 mg daily (n= 25) to placebo (n=25) on EBV viral infection in RRMS patients receiving anti-CD20 therapy.
The primary endpoint is reduction in cerebrospinal fluid levels of neurofilament light chain levels, and the key secondary endpoint is change in TSPO PET evidence of microglial activation.
Status: The protocol will be submitted to the Clinical Trials Information System (CTIS) by January 2025, and we aim to start inclusion in June 2025.
Participating centres
Norway
- Haukeland University Hospital, Bergen
- Stavanger University Hospital, Stavanger
- Førde Hospital, Førde
- Haugesund Hospital, Haugesund
- Oslo University Hospital, Oslo
- Akershus University Hospital, Lørenskog
- Vestre Viken Hospital, Drammen
Finland
- Turku University Hospital, Turku
Funding
- The Norwegian MS Society
- The Regional Health Authority of Western Norway
- Horizon Europe
- Meyer Nyquist Legacy
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- The University of Bergen
- Turku University Hospital, Turku
- Participating hospitals