Disease: Multiple Sclerosis
Type of study: Interventional trial
Coordinating investigator: Christopher E Kvistad
Study directors: Kjell-Morten Myhr & Charalampos Tzoulis
Information for patients: on this page (Norwegian only)
Background: Evidence suggests that mitochondrial dysfunction occurs in the brain of patients with MS and may play a particularly important role in the neurodegenerative processes underlying the pathogenesis of progression in MS. This mitochondrial dysfunction is suggested to compromise neuronal metabolism and survival, including ATP deficiency and decreased rate of mitochondrial NADH oxidation, leading to depletion of neuronal NAD, one of the most essential molecules for bioenergetics conversion and signalling in human cells.
The objective is to study whether oral supplementation with nicotinamide riboside (NR) as add-on to standard care, reduces disability progression in MS.
Design: This is a randomised double-blinded study where 300 patients, that have experienced worsening of disability during the last two years, receive oral 500 mg oral nicotinamide riboside (NR) twice daily (n=150) or placebo (n=150) for 30 months. The patients will attend nine visits that include clinical scorings, imaging, blood sampling, questionnaires, and patient reported outcomes.
The primary endpoint is the proportion of patients with 6 months confirmed disability progression, either by worsening of Expanded Disability Status Scale (EDSS), Nine-Hole-Peg-Test (9-HPT) or Timed 25 Foot Walking (T25FW) after two years of therapy.
Status: The first patient was included at Haukeland University Hospital in May 2023 and by end of 2024, about 40 patients are included. A total of 18 hospitals has expressed their interest in participation.
Participating centres
- Haukeland University Hospital, Bergen
- Stavanger University Hospital, Stavanger
- Haugesund Hospital Trust, Haugesund
- Førde Hospital Trust, Førde
- Oslo University Hospital, Oslo
- Akershus University Hospital, Lørenskog
- University Hospital of North Norway, Tromsø
- Nordland Hospital Trust, Bodø
- Namsos Hospital Trust, Namsos
- Olav’s University Hospital, Trondheim
- Molde Hospital Trust, Molde
- Ålesund Hospital Trust, Ålesund
- Sørlandet Hospital Trust, Kristiansand
- Telemark Hospital Trust, Skien
- Vestre Viken Hospital Trust, Drammen
- Vestfold Hospital Trust, Tønsberg
- Østfold Hospital Trust, Kalnes
- Lillehammer Hsopital Trust, Lillehammer
Funding
- The Regional Health Authority of Western Norway
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- The University of Bergen
- Participating hospitals
- Elysium Health (New York)