- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05546567
NOPARK Open Label Extension Study
November 25, 2022 updated by: Haukeland University Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 1200mg NR daily, divided into 600mg 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 Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Charalampos Tzoulis, PhD
- Phone Number: +47 94392305
- Email: charalampos.tzoulis@helse-bergen.no
Study Locations
-
-
Vestland
-
Bergen, Vestland, Norway, 5021
- Recruiting
- Haukeland University Hospital
-
Contact:
- Charalampos Tzoulis, PhD
- Phone Number: +47 94392305
- Email: charalampos.tzoulis@helse-bergen.no
-
Contact:
- Haakon Berven, MD
- Phone Number: +47 48495197
- Email: haakonberven@outlook.com
-
Principal Investigator:
- Charalampos Tzoulis, PhD
-
Sub-Investigator:
- Haakon Berven, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nicotinamide Riboside
Open Label.
Nicotinamide Riboside 1200mg x1 daily
|
1200mg x1 Nicotinamide Riboside
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: measurement of Adverse Events
Time Frame: 0-3 Years
|
To assess the safety profile of long-term treatment with oral NR 1200 mg daily.
|
0-3 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Outcome: total movement disorders society unified Parkinson disease rating scale (MDS-UPDRS) score. Range 0-199
Time Frame: 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.
|
0-3 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charalampos Tzoulis, PhD, Neur-Sysmed, Haukeland University Hospital, Norway
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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. Erratum In: Hum Exp Toxicol. 2018 Apr;37(4):448.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 28, 2022
Primary Completion (Anticipated)
December 31, 2025
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
September 15, 2022
First Submitted That Met QC Criteria
September 15, 2022
First Posted (Actual)
September 21, 2022
Study Record Updates
Last Update Posted (Actual)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 25, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 457567
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All data supporting te publication will be publicly shared with the exception of any sensitive information which can lead to participant identification, as defined by Norwegian law.
IPD Sharing Time Frame
At publication
IPD Sharing Access Criteria
We will publish open access.
The data will be publicly available
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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