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NOPARK Open Label Extension Study
Plain-language guide to NCT05546567: not phased interventional trial of NAD+, 400 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05546567
- Phase
- not phased
- Status
- active, not recruiting
- Start
- 2022-09-28
- Completion (planned or actual)
- 2025-06-20
- Participants
- 400 (estimated)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Safety Issues
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around NAD+.
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.
It had 1 arm (groups): Nicotinamide Riboside (experimental).
The registry classes the interventions as dietary supplement.
More on the Plan
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 study is multi-site, identical to NOPARK.
The primary endpoint of the study, which is safety, will be analyzed using descriptive statistics.
Who Took Part
Enrollment: 400 planned participants were the target.
It was open to people of any sex.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Provision of signed and dated informed consent form.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: current use of vitamin b3 supplementation or nr supplementation - other than in relation to the nopark study.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when NAD+ was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2022-09-28 with completion listed for 2025-06-20.
It ran at 1 site in Norway.
Its stated primary purpose is other.
What Was Measured
The main thing measured (primary outcome): Safety: measurement of Adverse Events (time frame: 0-3 Years).
It also tracked 1 secondary outcome, for example Clinical Outcome: total movement disorders society unified Parkinson disease rating scale (MDS-UPDRS) score. Range 0-199.
What This Means in Plain Language
Put simply, this is a not phased trial of NAD+ in 400 people.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.