Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— Norseman  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740722
• Other study ID #: 492199
• Status: Recruiting
• Phase: Phase 2
• Start date: May 3, 2023
• Est. completion date: December 30, 2027

Study information

• Verified date: June 2023
• Source: Haukeland University Hospital
• Contact: Kjell-Morten Myhr
• Phone: +47 55976031
• Email: kjell-morten.myhr[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Progressive Multiple Sclerosis
• Sclerosis

Intervention

Dietary Supplement:
• Nicotinamid riboside
500 mg x 2 po
• Placebo
Placebo tablets

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to month 30
Secondary	To determine the efficacy of NR compared with placebo, as reflected by EDSS	Proportion of patients with sustained disability progression over the treatment period	Baseline to month 30
Secondary	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	Baseline to month 30
Secondary	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	Baseline to month 30
Secondary	To determine the efficacy of NR compared with placebo, as reflected by total volume of T2 lesions on MRI scans of the brain	MRI	Baseline to month 24
Secondary	To determine the efficacy of NR compared with placebo, as reflected by formation of lesions	MRI	Baseline to month 24
Secondary	Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo	MRI	Baseline to month 24
Secondary	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	Baseline to month 30