Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHaukeland University Hospital
About this trial
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,
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotinamid riboside
Dietary supplement500 mg x 2 po
Placebo
Dietary supplementPlacebo tablets
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: PlaceboExperimental treatment 1 intervention
Group B: Nicotinamid RibosideExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to month 30Secondary outcomes
1
To determine the efficacy of NR compared with placebo, as reflected by EDSS
Proportion of patients with sustained disability progression over the treatment period
Time frame
Baseline to month 302
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
Time frame
Baseline to month 303
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
Time frame
Baseline to month 304
To determine the efficacy of NR compared with placebo, as reflected by total volume of T2 lesions on MRI scans of the brain
MRI
Time frame
Baseline to month 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov