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,
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
500 mg x 2 po
Placebo tablets
Haukeland University Hospital
Bergen, Norway
RECRUITINGProportion 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 30
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 30
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 30
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 30
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 24
To determine the efficacy of NR compared with placebo, as reflected by formation of lesions
MRI
Time frame: Baseline to month 24
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Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo
MRI
Time frame: Baseline to month 24
Time to onset of sustained disability progression over the treatment period
Increase in either EDSS, T25FW or 9HPT that is sustained for at least 6 months
Time frame: Baseline to month 30