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NCT Number: NCT05740722

Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis

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,

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Progressive Multiple Sclerosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Haukeland University Hospital

Bergen, 5019, Norway

Location status: Recruiting

Location contact

Kjell-Morten Myhr

CONTACT

[email protected]

+4755976031

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotinamid riboside

Dietary Supplement

500 mg x 2 po

Placebo

Dietary Supplement

Placebo tablets

Primary outcomes

  1. Proportion of patients with sustained disability progression over the treatment period

    Time frame: 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.

Secondary outcomes

  1. To determine the efficacy of NR compared with placebo, as reflected by EDSS

    Time frame: Baseline to month 30

    Proportion of patients with sustained disability progression over the treatment period

  2. To determine the efficacy of NR compared with placebo, as reflected by 25-footwalk

    Time frame: Baseline to month 30

    Proportion of patients with sustained disability progression over the treatment period

  3. To determine the efficacy of NR compared with placebo, as reflected by 9-Hole Peg test

    Time frame: Baseline to month 30

    Proportion of patients with sustained disability progression over the treatment period

  4. 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

    MRI

  5. To determine the efficacy of NR compared with placebo, as reflected by formation of lesions

    Time frame: Baseline to month 24

    MRI

  6. Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo

    Time frame: Baseline to month 24

    MRI

  7. Time to onset of sustained disability progression over the treatment period

    Time frame: Baseline to month 30

    Increase in either EDSS, T25FW or 9HPT that is sustained for at least 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Kjell-Morten Myhr

CONTACT

[email protected]

+47 55976031

Øivind Torkildsen

CONTACT

[email protected]

+4755977039

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Acronym: Norseman

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2023
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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