NOPARK Open Label Extension Study
Study Details
Study Description
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) 12000 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The primary objective of the NOPARK open label extension study is to monitor NR use for long term safety. The secondary objective of the NOPARK open label study is to monitor long term NR use among PD patients and observe the clinical progression of PD. The NOPARK open label extension study is an open label study, where subjects enrolled in the NOPARK study (ClinicalTrials.gov: NCT03816020), upon completion of the study, will be offered the NR study drug for continuous use, until the NOPARK study is completed and the primary end-point assessed (31/12/2025). The dose of NR is 12000mg NR daily, divided into 5600mg twice daily. The reason for the slightly higher dose compared to NOPARK (i.e., 200mg higher) is the fact that the active compound is now available in capsules of 300mg which cannot be divided. From a clinical and scientific perspective, given current knowledge of safety and efficacy of NR in PD, a dose of 1200 mg is both safe and of a higher potential benefit to patients. The study is multi-site, identical to NOPARK. The primary endpoint of the study, which is safety, will be analyzed using descriptive statistics. The secondary endpoint, which is if long-term NR use delays PD progression will be analyzed using the clinical MDS-UPDRS score. Exploratory objectives will assess PD progression relative to the general PD-population and whether long-term NR use affects methylation metabolism. Stratification of analyses is dependent on the duration of administered NR, sex and age. Exploratory stratification will be done based on results from biological data analysis based on data from NOPARK or blood samples collected in the NOPARK open label extension study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nicotinamide Riboside Open Label. Nicotinamide Riboside 1200mg x1 daily |
Dietary Supplement: Nicotinamide Riboside
1200mg x1 Nicotinamide Riboside
|
Outcome Measures
Primary Outcome Measures
- Safety: measurement of Adverse Events [0-3 Years]
To assess the safety profile of long-term treatment with oral NR 12000 mg daily.
Secondary Outcome Measures
- Clinical Outcome, Measure of MDS-UPDRS Score [0-3 Years]
To assess whether the progression of PD during the NOPARK open label extension study differs among individuals who used placebo and individuals who used NR for 52 weeks in the NOPARK study.
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Haukeland University Hospital
Investigators
- Principal Investigator: Charalampos Tzoulis, PhD, Neur-Sysmed, Haukeland University Hospital, Norway
Study Documents (Full-Text)
None provided.More Information
Publications
- Brakedal B, Dölle C, Riemer F, Ma Y, Nido GS, Skeie GO, Craven AR, Schwarzlmüller T, Brekke N, Diab J, Sverkeli L, Skjeie V, Varhaug K, Tysnes OB, Peng S, Haugarvoll K, Ziegler M, Grüner 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.
- 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.
- Conze DB, Crespo-Barreto J, Kruger CL. Safety assessment of nicotinamide riboside, a form of vitamin B(3). Hum Exp Toxicol. 2016 Nov;35(11):1149-1160. doi: 10.1177/0960327115626254. Epub 2016 Jul 11. Erratum in: Hum Exp Toxicol. 2018 Apr;37(4):448.
- Dollerup OL, Christensen B, Svart M, Schmidt MS, Sulek K, Ringgaard S, Stødkilde-Jørgensen H, Møller 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.
- 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, Neuhäuser-Berthold M, Poulsen M, Schlatter JR, van Loveren H, Albert O, de Sesmaisons Lecarré 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.
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