Type of study: Interventional trial
Coordinating investigator: Øivind Torkildsen
Study director: Kjell-Morten Myhr
Information for patients: on this page (Norwegian only).
Background: Novel insights from the MS research group indicate that infection with the Epstein-Barr Virus (EBV) is the leading cause of MS. As an EBV infection is persistent for life, the virus could function as a trigger or driver of MS-disease activity. If results from a clinical trial could confirm that targeting EBV reduces MS-disease activity, it would result in a paradigmatic change in our understanding of MS and the management of the disease. In collaboration with researchers at Harvard University, Boston, USA, we have identified a highly interesting candidate drug targeting EBV, not yet evaluated in MS patients. This trial could lead to a new paradigm in MS therapy, as it will evaluate a drug that may target the underlying cause of the disease.
The objective of this study is to investigate the safety and efficacy of tenofovir alafenamide (TAF) on Epstein-Barr virus infection in patients with relapsing-remitting MS (RRMS).
Design: This is a randomised double-blinded, placebo-controlled trial comparing the safety and efficacy of tenofovir alafenamide fumarate (TAF) 25 mg daily (n= 25) to placebo (n=25) on EBV viral infection in stable RRMS patients receiving natalizumab therapy.
The primary endpoint is safety and tolerability of the drug, and the key secondary endpoint is change in EBV shedding in the saliva during 6 months of treatment.
Status: Inclusion of patients started early 2024, and by December 2024, 41/50 patients have been included.
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
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
- Participating hospitals
- Gilead Sciences, USA