Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis

Phase 2

Recruiting

• Conditions: Multiple Sclerosis; Progressive Multiple Sclerosis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Nicotinamid riboside

• Registration Number: NCT05740722
• Lead Sponsor: Haukeland University Hospital

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)

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-02-23
• Study Start: 2023-05-03
• Status Verified: 2023-06
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11
• Primary Completion: 2027-08-01
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo vs study drug
Nicotinamid Riboside	Nicotinamid riboside	Placebo vs study drug

Primary Outcome Measures

Name	Time	Method
Proportion of patients with sustained disability progression over the treatment period	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

Name	Time	Method
Time to onset of sustained disability progression over the treatment period	Baseline to month 30	Increase in either EDSS, T25FW or 9HPT that is sustained for at least 6 months
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
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
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
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
To determine the efficacy of NR compared with placebo, as reflected by formation of lesions	Baseline to month 24	MRI
Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo	Baseline to month 24	MRI

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway