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Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis (Norseman)

Primary Purpose

Multiple Sclerosis, Progressive Multiple Sclerosis

Status
Recruiting
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Nicotinamid riboside
Placebo
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring nicotinamid riboside

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo

Nicotinamid Riboside

Arm Description

Placebo vs study drug

Placebo vs study drug

Outcomes

Primary Outcome Measures

Proportion of patients with sustained disability progression over the treatment period
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

To determine the efficacy of NR compared with placebo, as reflected by EDSS
Proportion of patients with sustained disability progression over the treatment period
To determine the efficacy of NR compared with placebo, as reflected by 25-footwalk
Proportion of patients with sustained disability progression over the treatment period
To determine the efficacy of NR compared with placebo, as reflected by 9-Hole Peg test
Proportion of patients with sustained disability progression over the treatment period
To determine the efficacy of NR compared with placebo, as reflected by total volume of T2 lesions on MRI scans of the brain
MRI
To determine the efficacy of NR compared with placebo, as reflected by formation of lesions
MRI
Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo
MRI
Time to onset of sustained disability progression over the treatment period
Increase in either EDSS, T25FW or 9HPT that is sustained for at least 6 months

Full Information

First Posted
January 30, 2023
Last Updated
June 21, 2023
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05740722
Brief Title
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis
Acronym
Norseman
Official Title
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
August 1, 2027 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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,
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Progressive Multiple Sclerosis
Keywords
nicotinamid riboside

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomised placebo-controlled trial. Experimental: Placebo Placebo vs study drug (Nicotinamid riboside 500 mg x 2 po)
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo vs study drug
Arm Title
Nicotinamid Riboside
Arm Type
Experimental
Arm Description
Placebo vs study drug
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamid riboside
Intervention Description
500 mg x 2 po
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets
Primary Outcome Measure Information:
Title
Proportion of patients with sustained disability progression over the treatment period
Description
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.
Time Frame
Baseline to month 30
Secondary Outcome Measure Information:
Title
To determine the efficacy of NR compared with placebo, as reflected by EDSS
Description
Proportion of patients with sustained disability progression over the treatment period
Time Frame
Baseline to month 30
Title
To determine the efficacy of NR compared with placebo, as reflected by 25-footwalk
Description
Proportion of patients with sustained disability progression over the treatment period
Time Frame
Baseline to month 30
Title
To determine the efficacy of NR compared with placebo, as reflected by 9-Hole Peg test
Description
Proportion of patients with sustained disability progression over the treatment period
Time Frame
Baseline to month 30
Title
To determine the efficacy of NR compared with placebo, as reflected by total volume of T2 lesions on MRI scans of the brain
Description
MRI
Time Frame
Baseline to month 24
Title
To determine the efficacy of NR compared with placebo, as reflected by formation of lesions
Description
MRI
Time Frame
Baseline to month 24
Title
Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo
Description
MRI
Time Frame
Baseline to month 24
Title
Time to onset of sustained disability progression over the treatment period
Description
Increase in either EDSS, T25FW or 9HPT that is sustained for at least 6 months
Time Frame
Baseline to month 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Varhaug
Phone
+47 55970031
Email
kristin.nielsen.varhaug@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Øivind Torkildsen
Phone
+4755977039
Email
oivind.fredvik.grytten.torkildsen@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjell-Morten Myhr
Organizational Affiliation
Haukeland University Hopsital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5019
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Varhaug
Phone
+4755970032
Email
kristin.nielsen.varhaug@helse-bergen.no

12. IPD Sharing Statement

Plan to Share IPD
No

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Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis

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