NOPARK Open Label Extension Study

NCT05546567 | Active Not Recruiting DMC

• 1 other identifier: 457567
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol describes the NOPARK Open Label Extension Study. The NOPARK Open Label Extension study is an optional extension of the clinical phase II NOPARK study. Participants who have been included in the NOPARK study will upon completing their participation in the NOPARK study (i.e., after 52 weeks) be offered to receive the study drug Nicotinamide Riboside (NR) 1200 mg P.O. per day, until the NOPARK trial is completed, and the data analyzed with a conclusion of the primary outcome. Individuals enrolled into the NOPARK Open Label Extension Study will be followed with yearly visits. The goal of the NOPARK Open Label Extension Study is to monitor long term safety and study long term neuroprotective and other biological effects of NR use.

Conditions

Safety Issues

Keywords

Parkinson's disease; Nicotinamide Riboside; Open Label

Outcome Measures

Primary Outcomes (1)

• Safety: measurement of Adverse Events

  To assess the safety profile of long-term treatment with oral NR 1200 mg daily.

  0-3 Years

Secondary Outcomes (1)

• Clinical Outcome: total movement disorders society unified Parkinson disease rating scale (MDS-UPDRS) score. Range 0-199

  0-3 Years

Study Arms (1)

Nicotinamide Riboside

EXPERIMENTAL

Open Label. Nicotinamide Riboside 1200mg x1 daily

Dietary Supplement: Nicotinamide Riboside

Interventions

Nicotinamide Riboside DIETARY_SUPPLEMENT

1200mg x1 Nicotinamide Riboside

Nicotinamide Riboside

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Participated in the NOPARK study

You may not qualify if:

• Current use of vitamin B3 supplementation or NR supplementation - other than in relation to the NOPARK study
• Known allergic reactions to components of the NR
• Physical or psychiatric illness that makes them unavailable for follow-up and participation.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

Location

Related Publications (5)

• Brakedal B, Dolle C, Riemer F, Ma Y, Nido GS, Skeie GO, Craven AR, Schwarzlmuller T, Brekke N, Diab J, Sverkeli L, Skjeie V, Varhaug K, Tysnes OB, Peng S, Haugarvoll K, Ziegler M, Gruner R, Eidelberg D, Tzoulis C. The NADPARK study: A randomized phase I trial of nicotinamide riboside supplementation in Parkinson's disease. Cell Metab. 2022 Mar 1;34(3):396-407.e6. doi: 10.1016/j.cmet.2022.02.001.

  PMID: 35235774 BACKGROUND

• Dollerup OL, Christensen B, Svart M, Schmidt MS, Sulek K, Ringgaard S, Stodkilde-Jorgensen H, Moller N, Brenner C, Treebak JT, Jessen N. A randomized placebo-controlled clinical trial of nicotinamide riboside in obese men: safety, insulin-sensitivity, and lipid-mobilizing effects. Am J Clin Nutr. 2018 Aug 1;108(2):343-353. doi: 10.1093/ajcn/nqy132.

  PMID: 29992272 BACKGROUND

• Conze DB, Crespo-Barreto J, Kruger CL. Safety assessment of nicotinamide riboside, a form of vitamin B3. Hum Exp Toxicol. 2016 Nov;35(11):1149-1160. doi: 10.1177/0960327115626254. Epub 2016 Jul 11.

  PMID: 26791540 BACKGROUND

• Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019 Jul 5;9(1):9772. doi: 10.1038/s41598-019-46120-z.

  PMID: 31278280 BACKGROUND

• EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA); Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Prieto Maradona M, Marchelli R, Neuhauser-Berthold M, Poulsen M, Schlatter JR, van Loveren H, Albert O, de Sesmaisons Lecarre A, Knutsen HK. Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283. EFSA J. 2021 Nov 12;19(11):e06843. doi: 10.2903/j.efsa.2021.6843. eCollection 2021 Nov.

  PMID: 34804232 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Charalampos Tzoulis, PhD

  Neur-Sysmed, Haukeland University Hospital, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label single group

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: September 28, 2022
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At publication
• Access Criteria: We will publish open access. The data will be publicly available

Locations

NO (1)