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,
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Proportion of patients with sustained disability progression over the treatment period — Baseline to month 30 Defined as an increase in either expanded disability status scale (EDSS), timed 25 foot -walk test (T25W) or 9-hole-peg test.
EDSS is measured in scores from 0 - 10. The higher the score the less ambulatory ability. Progression is defined as an increase of \>/=1.0 point if baseline EDSS is \</= 5.5 or an increase of \>/=0.5 point if baseline EDSS is \>/= 5.5. Progression in T25WT and 9HPT is defined as an increase of 20% from baseline measures in minutes/seconds.
Trial sites (1)
Facility
City
Region
Status
Haukeland University Hospital
Bergen
Norway
Recruiting
More Haukeland University Hospital trials in Norway
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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