NCT05740722RecruitingPhase 2
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
Source: ClinicalTrials.gov · Last updated 11 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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,
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 30 Jan 2023
- Start date
- 3 May 2023
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Haukeland University Hospital
- Diseases
- Multiple sclerosis
- NCT number
- NCT05740722
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- From 3 May 2023 to the primary completion date, 1 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Neoplastic disease at baseline
- Previous history of malignant melanoma or breast cancer
- Stable phase of a progressive disease course
- Dementia or other neurodegenerative disorder at baseline visit
- Comorbidity (psychiatric or somatic) that precludes study participation
- Genetically confirmed mitochondrial disease or metabolic disorder
Other
- A diagnosis of relapsing MS according to the revisions of the McDonald criteria
- Pregnancy or lactating female patients
- Use of high dose vitamin B3 supplementation within 30 days of enrolment
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.