Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis

NCT05740722 | Recruiting Phase 2 DMC

• 1 other identifier: 492199
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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,

Conditions

Multiple Sclerosis; Progressive Multiple Sclerosis

Keywords

nicotinamid riboside

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to month 30

Secondary Outcomes (7)

• To determine the efficacy of NR compared with placebo, as reflected by EDSS

  Baseline to month 30

• To determine the efficacy of NR compared with placebo, as reflected by 25-footwalk

  Baseline to month 30

• To determine the efficacy of NR compared with placebo, as reflected by 9-Hole Peg test

  Baseline to month 30

• 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

• To determine the efficacy of NR compared with placebo, as reflected by formation of lesions

  Baseline to month 24

Study Arms (2)

Placebo

EXPERIMENTAL

Placebo vs study drug

Dietary Supplement: Placebo

Nicotinamid Riboside

EXPERIMENTAL

Placebo vs study drug

Dietary Supplement: Nicotinamid riboside

Interventions

Nicotinamid riboside DIETARY_SUPPLEMENT

500 mg x 2 po

Nicotinamid Riboside

Placebo DIETARY_SUPPLEMENT

Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5019, Norway

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kjell-Morten Myhr

  Haukeland University Hopsital

  STUDY DIRECTOR

Central Study Contacts

Kjell-Morten Myhr

CONTACT

+47 55976031; kjell-morten.myhr@helse-bergen.no

Øivind Torkildsen

CONTACT

+4755977039; oivind.fredvik.grytten.torkildsen@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised placebo-controlled trial. Experimental: Placebo Placebo vs study drug (Nicotinamid riboside 500 mg x 2 po)

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 23, 2023
• Study Start: May 3, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 11, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)