Norseman: Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05740722
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 58
• Patients Per Site Per Month: 5.2

Study Details

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,

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

• Study Type: Interventional
• Anticipated 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)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
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2027
• Anticipated Study Completion Date: Dec 30, 2027

Arms and Interventions

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

Primary Outcome Measures

1. Time to onset of sustained disability progression over the treatment period [Baseline to month 30]

   Time to onset of sustained disability progression, 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 [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 [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 [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 [Baseline to month 24]

   MRI

5. To determine the efficacy of NR compared with placebo, as reflected by formation of lesions [Baseline to month 24]

   MRI

6. Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo [Baseline to month 24]

   MRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway	5019

Sponsors and Collaborators

• Haukeland University Hospital

Investigators

• Study Director: Kjell-Morten Myhr, Haukeland University Hopsital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT05740722
• Other Study ID Numbers: 492199
• First Posted: Feb 23, 2023
• Last Update Posted: Feb 23, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis

Study Results

No Results Posted as of Feb 23, 2023