Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nicotinamid riboside, Placebo.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Progressive Multiple Sclerosis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
Overview
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,
Detailed description
After being informed about the study and risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry.
At baseline patients who meet the eligibility requirements will be randomised in a double- blinded manner (patient and investigator) in a 1:1 ratio to nicotinamide riboside (1000 mg daily) or placebo (once a day)
Interventions
- Dietary supplement Nicotinamid riboside
500 mg x 2 po - Dietary supplement Placebo
Placebo tablets
Primary outcome measures
- Proportion of patients with sustained disability progression over the treatment period [Time frame: Baseline to month 30]
Secondary outcome measures (7)
- To determine the efficacy of NR compared with placebo, as reflected by EDSS [Time frame: Baseline to month 30]
- To determine the efficacy of NR compared with placebo, as reflected by 25-footwalk [Time frame: Baseline to month 30]
- To determine the efficacy of NR compared with placebo, as reflected by 9-Hole Peg test [Time frame: Baseline to month 30]
- To determine the efficacy of NR compared with placebo, as reflected by total volume of T2 lesions on MRI scans of the brain [Time frame: Baseline to month 24]
- To determine the efficacy of NR compared with placebo, as reflected by formation of lesions [Time frame: Baseline to month 24]
- Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo [Time frame: Baseline to month 24]
- Time to onset of sustained disability progression over the treatment period [Time frame: Baseline to month 30]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Haukeland University Hospital — Bergen
Identifiers
NCT: NCT05740722 · 492199