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Parkinson DiseasePhase 3NOPARKNCT03568968

A Randomized Controlled Trial of Nicotinamide Riboside Supplementation in Early Parkinson's Disease

A Phase 3 study testing Nicotinamide Riboside in people with Parkinson Disease, run by Haukeland University Hospital at 11 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

NOPARK is a double-blinded randomized controlled phase II trial, with the aim to assess the efficacy of nicotinamide adenine dinucleotide (NAD)-replenishment therapy in the form of oral nicotinamide riboside (NR) in delaying the progression of early Parkinson's disease (PD). Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Nicotinamide Riboside
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
410 participants
Where
11 sitesNorway
Study dates
6 May 2020to 17 Jun 2025
Phase
Phase 3
Are there results?
None posted in the registry

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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for Parkinson's disease
  • [¹²³I]FP-CIT single photon emission CT (DaTscan) confirming nigrostriatal degeneration
  • Diagnosed with PD within 2 years from enrolment
  • Hoehn and Yahr score < 3 at enrolment
  • Optimal symptomatic therapy, not requiring adjustments, for at least 1 month.
  • Age equal to or greater than 35 years at time of enrolment.

Who cannot join

  • Dementia or other neurodegenerative disorder at baseline visit
  • Diagnosed with atypical parkinsonism or vascular parkinsonism
  • Any psychiatric disorder that would interfere with compliance in the study.
  • Any severe somatic illness that would make the individual unable to comply and participate in the study.
  • Use of high dose vitamin B3 supplementation within 30 days of enrolment
  • Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
  • Genetically confirmed mitochondrial disease

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Norway11 sites

  • Arendal Hospital

    Arendal

  • Haukeland University Hospital

    Bergen

  • Bodø Hospital

    Bodø, Nordland

  • Vestre Viken Hospital

    Drammen

  • Førde sykehus

    Førde

  • Østfold Hospital

    Fredrikstad, Østland

  • Haugesund Hospital

    Haugesund

  • Molde sjukehus

    Molde

  • Akershus university hospital

    Oslo

  • Oslo University Hospital

    Oslo

  • University Hospital of North Norway

    Tromsø

Other trials in Norway

About this study

Official title: A Randomized Controlled Trial of Nicotinamide Riboside Supplementation in Early Parkinson's Disease: the NOPARK Study

NOPARK is a double-blinded randomized controlled phase II trial, with the aim to assess the efficacy of nicotinamide adenine dinucleotide (NAD)-replenishment therapy in the form of oral nicotinamide riboside (NR) in delaying the progression of early Parkinson's disease (PD). A total of 400 persons with early stage Parkinson's disease will be enrolled, randomized on nicotinamide riboside (NR) 500mg x 2 per day or placebo, and followed for 52 weeks.

Read the detailed description

NOPARK is a multi-center, double-blinded randomized controlled trial, with the aim to assess the efficacy of NAD-replenishment therapy in the form of oral nicotinamide riboside (NR) in delaying the progression of early Parkinson's disease (PD). Individuals with PD (n = 400) will be recruited from multiple centers across Norway. Eligible participants must have been diagnosed with PD within 2 years of study enrollment and meet the trial's inclusion criteria. All participants will be given a standard PD-treatment regimen comprising selegiline 10 mg/day and oral levodopa (Sinemet or Madopar) at a dose of 100mg x 3, 150mg x3, or 200mg x 3 per day. The PD-treatment regimen will be frozen at baseline and remain stable throughout the duration of the study. At baseline, participants will be randomized on a 1:1 ratio on either nicotinamide riboside (NR) 500mg x 2 per day or placebo. Both the participants and the investigators will be blinded. The trial duration will be 52 weeks, during which participants will be assessed at baseline, 13, 26, 39 and 52 weeks. Measures include clinical evaluation using established scales for motor and non-motor dysfunction, as well as quality of life, 123I-N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-iodophenyl) nortropane ([¹²³I]FP-CIT) single photon emission tomography (DaTscan), magnetic resonance imaging (MRI) of the brain, blood safety tests, and blood sampling for metabolomics, transcriptomics, and other exploratory analyses. The primary outcome of the study is the total score of the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

Being tested
Nicotinamide Riboside, Placebo
Keywords
Parkinson's Disease, NAD metabolism, Mitochondria, Nicotinamide Riboside
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotinamide RibosideDietary supplement

    Also called NR, NAD, TruNiagen

    Nicotinamide Riboside 500mg administered two times a day. Given as capsules. Duration of the trial; 52 weeks.

  • PlaceboOther

    Placebo drug, administered two times a day. Given as capsules. Duration of the trial; 52 weeks.

Study groups in NCT03568968
Study groupRoleWhat they receive
Nicotinamide RibosideExperimentalnicotinamide riboside, 1000mg daily for the duration of the trial (52 weeks). Dosage form is capsules.
Receives: Dietary Supplement: Nicotinamide Riboside
Placebo ComparatorPlacebo comparatorPlacebo capsules, no active ingredients.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease severity assessed by the total MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale): sum of subsections I, II, and III

    The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assesses motor and non-motor symptoms of PD through four parts, with individual items rated on a 0-4 scale. Subscores are summed to provide a total score ranging from 0 to 260, with higher scores indicating greater disability. The primary outcome will be the MDS-UPDRS Total Score (sum of parts I, II, and III).

    Measured: From baseline to the end of treatment at 52 weeks

Secondary outcomes (8)

  1. Severity of motor symptoms in PD.

    Change from baseline in the MDS-UPDRS Part III in the ON-medication state.

    Measured: From baseline to the end of treatment at 52 weeks

  2. Severity of dopaminergic nigrostriatal denervation, assessed by [¹²³I]FP-CIT single photon emission CT (DaTscan)

    Change from baseline in the mean striatal binding ratio (SBR) of the putamen, bilaterally, as measured [¹²³I]FP-CIT Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT, DaTscan).

    Measured: From baseline to the end of treatment at 52 weeks

  3. Severiy of non-motor symptoms in daily living in PD

    Change from baseline in the MDS-UPDRS Part I in the ON-medication state

    Measured: From baseline to the end of treatment at 52 weeks

  4. Severity of motor aspects of experiences of daily living in PD.

    Change from baseline in the MDS-UPDRS Part II

    Measured: From baseline to the end of treatment at 52 weeks

  5. Severity of non-motor symptoms of PD assessed by the Non-Motor Symptoms Assessment Scale

    Change from baseline in the NMSS Score in the ON-medication state. Non-Motor Symptoms Scale (NMSS) has 30 items, score range is 0-360 with higher scores indicating a worse outcome.

    Measured: From baseline to the end of treatment at 52 weeks

  6. Change in the clinical severity of cognitive decline assessed by the Montreal Cognitive Assessment (MoCA) scale

    Montreal Cognitive Assessment (MoCA), score range is 0-30 with lower scores indicating a worse outcome.

    Measured: From baseline to the end of treatment at 52 weeks

  7. Change in quality of life assessed by the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire.

    Quality of Life assessment (EuroQuality of Life Five Dimensions - EQ-5D-5L).

    Measured: From baseline to the end of treatment at 52 weeks

  8. Hoehn and Yahr stage of PD

    Hoehn and Yahr scale distinguishes between five stages in PD: Stage 1: Unilateral disease; Stage 2: Bilateral disease without impairment of balance; Stage 3: Bilateral disease with postural instability but physically independent; Stage 4: Severe disability; still able to walk or stand unassisted; Stage 5: Confinement to bed or wheelchair unless aided.

    Measured: From baseline to the end of treatment at 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start6 May 2020
  3. Primary completion17 Jun 2025
  4. Study completion17 Jun 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized double-blinded study. N = 400 participants are randomized in a 1:1 ratio to either nicotinamide riboside (500 mg x 2 per day) or placebo.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03568968
Sponsor's protocol ID
2017/2083
Acronym
NOPARK
Status last verified
Sep 2025
First submitted
14 Jun 2018
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brakedal B, Skeie GO, Derad C, Alstadhaug KB, Anundskas I, Berven H, Biermann M, Bjornara KA, Torres Cleuren YN, Dalbro SEJ, Eidelberg D, Foldnes K, Fortes G, Haugarvoll K, Herlofson K, Hustad E, HogenEsch RI, Johanson GAS, Johnsen SH, Kunszt K, Kverneng S, Labusau A, Lie IH, Lilleng H, Lundervold K, Lundqvist C, Ma Y, McCann A, Njolstad TH, Pihlstrom L, Riemer F, Rognerud AK, Sheard E, Simonsen AM, Storm E, Svensen M, Toker L, Tunold JA, Dolle C, Friede T, Tzoulis C. Nicotinamide Riboside for Patients With Early-Stage Parkinson Disease: The NOPARK Randomized Clinical Trial. JAMA. 2026 Oct 8:e2618828. doi: 10.1001/jama.2026.18828. Online ahead of print.

    PubMed 42848371

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nicotinamide Riboside in people with Parkinson Disease, run by Haukeland University Hospital at 11 sites 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease severity assessed by the total MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale): sum of subsections I, II, and III (time frame: From baseline to the end of treatment at 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03568968, which also lists 1 linked publication.

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 26 Sep 2025.

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