The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis (Norseman)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05740722
Recruitment Status : Recruiting
First Posted : February 23, 2023
Last Update Posted : January 11, 2024
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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,


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Progressive Multiple Sclerosis Dietary Supplement: Nicotinamid riboside Dietary Supplement: Placebo Phase 2

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)

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomised placebo-controlled trial. Experimental: Placebo Placebo vs study drug (Nicotinamid riboside 500 mg x 2 po)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
Actual Study Start Date : May 3, 2023
Estimated Primary Completion Date : August 1, 2027
Estimated Study Completion Date : December 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Placebo
Placebo vs study drug
 Dietary Supplement: Placebo
Placebo tablets
Experimental: Nicotinamid Riboside
Placebo vs study drug
 Dietary Supplement: Nicotinamid riboside
500 mg x 2 po


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05740722


Contacts
Layout table for location contacts
Contact: Kjell-Morten Myhr +47 55976031 kjell-morten.myhr@helse-bergen.no
Contact: Øivind Torkildsen +4755977039 oivind.fredvik.grytten.torkildsen@helse-bergen.no

Locations
Layout table for location information
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5019
Contact: Kjell-Morten Myhr    +4755976031    kjell-morten.myhr@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Layout table for investigator information
Study Director: Kjell-Morten Myhr Haukeland University Hopsital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT05740722    
Other Study ID Numbers: 492199
First Posted: February 23, 2023    Key Record Dates
Last Update Posted: January 11, 2024
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
nicotinamid riboside
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes