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RECRUITINGPhase 2INTERVENTIONAL

Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis

Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form for study participation. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

Nicotinamid riboside

500 mg x 2 po

DIETARY_SUPPLEMENT

Placebo

Placebo tablets

Locations (1)

Haukeland University Hospital
Bergen, Norway