Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis
Recruiting · NCT05740722 · Interventional (participants receive a specific treatment) · Lead sponsor: Haukeland University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Nicotinamid ribosidePlacebo
What this trial is about
The purpose of this study is to assess the safety and efficacy of Nicotinamide riboside (NR) for treatment of patients with progressive multiple sclerosis. The main question it aims to answer is: • Does NR delay disability progression in progressive multiple sclerosis? Participants will be treated with NR or placebo for 30 months,
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- A diagnosis of progressive MS (secondary; SPMS or primary; PPMS) according to the 2013 revisions of clinical course of multiple sclerosis and the 2017 revisions of the McDonald criteria.
- Aged 18-65 years.
- EDSS 3-6.5
- Able to perform T25FW test
- The participant must have documented evidence of disability progression observed during the 24 months before screening.
- With or without a stable disease modifying therapy during the last three months.
- Written informed consent for study participation.
Exclusion criteria
- A diagnosis of relapsing MS according to the revisions of the McDonald criteria
- Neoplastic disease at baseline
- Previous history of malignant melanoma or breast cancer
- Stable phase of a progressive disease course
- Pregnancy or lactating female patients
- Dementia or other neurodegenerative disorder at baseline visit
- Comorbidity (psychiatric or somatic) that precludes study participation
- Use of high dose vitamin B3 supplementation within 30 days of enrolment
- Genetically confirmed mitochondrial disease or metabolic disorder
Where it is running
1 location listed.
- Haukeland University Hospital - Bergen, Norway