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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05740722
Other study ID # 492199
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 3, 2023
Est. completion date December 30, 2027

Study information

Verified date June 2023
Source Haukeland University Hospital
Contact Kjell-Morten Myhr
Phone +47 55976031
Email kjell-morten.myhr@helse-bergen.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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,


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 30, 2027
Est. primary completion date August 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Nicotinamid riboside
500 mg x 2 po
Placebo
Placebo tablets

Locations

Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (1)

Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Baseline to month 30
Secondary To determine the efficacy of NR compared with placebo, as reflected by EDSS Proportion of patients with sustained disability progression over the treatment period Baseline to month 30
Secondary 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 Baseline to month 30
Secondary 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 Baseline to month 30
Secondary To determine the efficacy of NR compared with placebo, as reflected by total volume of T2 lesions on MRI scans of the brain MRI Baseline to month 24
Secondary To determine the efficacy of NR compared with placebo, as reflected by formation of lesions MRI Baseline to month 24
Secondary Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo MRI Baseline to month 24
Secondary 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 Baseline to month 30
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