Multiple SclerosisPhase 2NorsemanNCT05740722
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis
A Phase 2 study testing Nicotinamid riboside in people with Multiple Sclerosis and Progressive Multiple Sclerosis, run by Haukeland University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Progressive Multiple Sclerosis
- What is being tested?
- Nicotinamid riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 3 May 2023to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5019
Kjell-Morten Myhr, +4755976031, kjell-morten.myhr@helse-bergen.no
About this study
Official title: Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
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,
Read the 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)
- Conditions
- Multiple Sclerosis, Progressive Multiple Sclerosis
- Being tested
- Nicotinamid riboside, Placebo
- Keywords
- nicotinamid riboside
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamid ribosideDietary supplement
500 mg x 2 po
PlaceboDietary supplement
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Placebo vs study drug Receives: Dietary Supplement: Placebo |
| Nicotinamid Riboside | Experimental | Placebo vs study drug Receives: Dietary Supplement: Nicotinamid riboside |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to month 30
Secondary outcomes (7)
To determine the efficacy of NR compared with placebo, as reflected by EDSS
Proportion of patients with sustained disability progression over the treatment period
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to month 24
To determine the efficacy of NR compared with placebo, as reflected by formation of lesions
MRI
Measured: Baseline to month 24
Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo
MRI
Measured: 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
Measured: Baseline to month 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start3 May 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised placebo-controlled trial. Experimental: Placebo Placebo vs study drug (Nicotinamid riboside 500 mg x 2 po)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjell-Morten Myhr, Study director, Haukeland University Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740722
- Sponsor's protocol ID
- 492199
- Acronym
- Norseman
- Status last verified
- Jun 2023
- First submitted
- 30 Jan 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
- ClinicalTrials.gov ID
- NCT05740722
- Acronym / sponsor ID
- Norseman / 492199
- Conditions
- Multiple Sclerosis, Progressive Multiple Sclerosis
- Keywords
- nicotinamid riboside
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised placebo-controlled trial. Experimental: Placebo Placebo vs study drug (Nicotinamid riboside 500 mg x 2 po)
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Dietary Supplement: PlaceboPlacebo vs study drug |
| Nicotinamid Riboside | Experimental | Dietary Supplement: Nicotinamid ribosidePlacebo vs study drug |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamid riboside500 mg x 2 po | Dietary supplement | Nicotinamid Riboside |
| PlaceboPlacebo tablets | Dietary supplement | Placebo |
Primary outcome
Proportion of patients with sustained disability progression over the treatment period
Time frame: Baseline to month 30
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.
7 secondary outcomes
To determine the efficacy of NR compared with placebo, as reflected by EDSS
Time frame: Baseline to month 30
To determine the efficacy of NR compared with placebo, as reflected by 25-footwalk
Time frame: Baseline to month 30
To determine the efficacy of NR compared with placebo, as reflected by 9-Hole Peg test
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
Time frame: Baseline to month 24
To determine the efficacy of NR compared with placebo, as reflected by formation of lesions
Time frame: Baseline to month 24
Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo
Time frame: Baseline to month 24
Time to onset of sustained disability progression over the treatment period
Time frame: Baseline to month 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
Active, not recruitingPhase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis Complex, Epilepsy
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kjell-Morten Myhr study director
Haukeland University Hopsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamid riboside in people with Multiple Sclerosis and Progressive Multiple Sclerosis, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kjell-Morten Myhr (+47 55976031, kjell-morten.myhr@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with sustained disability progression over the treatment period (time frame: Baseline to month 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.