Clinical trial NCT05740722: Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis
Official title: Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Sclerosis
Progressive Multiple Sclerosis
Keywords: nicotinamid riboside
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised placebo-controlled trial. Experimental: Placebo Placebo vs study drug (Nicotinamid riboside 500 mg x 2 po)
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with sustained disability progression over the treatment period
timeFrame: Baseline to month 30
Secondary outcomes:
measure: To determine the efficacy of NR compared with placebo, as reflected by EDSS
timeFrame: Baseline to month 30
measure: To determine the efficacy of NR compared with placebo, as reflected by 25-footwalk
timeFrame: Baseline to month 30
measure: To determine the efficacy of NR compared with placebo, as reflected by 9-Hole Peg test
timeFrame: Baseline to month 30
measure: To determine the efficacy of NR compared with placebo, as reflected by total volume of T2 lesions on MRI scans of the brain
timeFrame: Baseline to month 24
measure: To determine the efficacy of NR compared with placebo, as reflected by formation of lesions
timeFrame: Baseline to month 24
measure: Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo
timeFrame: Baseline to month 24
measure: Time to onset of sustained disability progression over the treatment period
timeFrame: Baseline to month 30
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hopsital
name: Kjell-Morten Myhr
role: STUDY_DIRECTOR
References: