Nicotinamide riboside for treating progressive multiple sclerosis
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
This study is testing if a supplement called Nicotinamide riboside can help people with progressive multiple sclerosis slow down their disability over 30 months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen) |
| Trial ID | NCT05740722 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Nicotinamide riboside (NR) in patients with progressive multiple sclerosis. Participants will be randomly assigned to receive either NR or a placebo for a duration of 30 months. The primary objective is to determine whether NR can delay disability progression in individuals diagnosed with progressive forms of MS. The study employs a double-blind design to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of progressive multiple sclerosis and documented evidence of disability progression.
Not a fit: Patients with relapsing forms of multiple sclerosis or those with certain comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could slow down the progression of disability in patients with progressive multiple sclerosis.
How similar studies have performed: While the use of nicotinamide riboside is a novel approach in this context, similar studies targeting metabolic pathways in MS have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bergen
- Haukeland University Hospital — Bergen, Norway (Recruiting)
Study contacts
- Study coordinator: Kjell-Morten Myhr
- Email: kjell-morten.myhr@helse-bergen.no
- Phone: +47 55976031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.