Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2027-12-30

Brief Summary

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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,

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Detailed Description

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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)

Conditions

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Multiple Sclerosis Progressive Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo vs study drug

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo tablets

Nicotinamid Riboside

Placebo vs study drug

Group Type EXPERIMENTAL

Nicotinamid riboside

Intervention Type DIETARY_SUPPLEMENT

500 mg x 2 po

Interventions

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Nicotinamid riboside

500 mg x 2 po

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo tablets

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No