Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosi
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
What it found
No result yet.
What was tested
Treatment tested
- Nicotinamid riboside
Placebo
- Placebo
What it measured
Main measures
Proportion of patients with sustained disability progression over the treatment period
Baseline to month 30
Disability progressionWalking and mobility
Other measures (7)
To determine the efficacy of NR compared with placebo, as reflected by EDSS
Baseline to month 30
Disability progressionTo determine the efficacy of NR compared with placebo, as reflected by 25-footwalk
Baseline to month 30
Disability progressionWalking and mobilityTo determine the efficacy of NR compared with placebo, as reflected by 9-Hole Peg test
Baseline to month 30
Disability progressionTo determine the efficacy of NR compared with placebo, as reflected by total volume of T2 lesions on MRI scans of the brain
Baseline to month 24
MRI lesionsTo determine the efficacy of NR compared with placebo, as reflected by formation of lesions
Baseline to month 24
MRI lesionsChanges in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo
Baseline to month 24
MRI lesionsBrain volume lossTime to onset of sustained disability progression over the treatment period
Baseline to month 30
Disability progression
Who could take part
Progressive MS · 18 to 65 · EDSS 3 to 6.5
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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,
Papers
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History
Started
May 2023
Main results due
Aug 2027
Finished
Dec 2027