NOPARK Open Label Extension Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Safety Issues

Clinical Trial Details

NCT number	NCT05546567
Study type	Interventional
Source	Haukeland University Hospital
Contact	Charalampos Tzoulis, PhD
Phone	94392305
Email	Charalampos.Tzoulis@helse-bergen.no
Status	Recruiting
Phase	N/A
Start date	September 28, 2022
Completion date	December 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04485481` - Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers	Phase 1
Completed	`NCT03473236` - Phase 1A Safety Trial of Inhaled PK10571 (GB002)	Phase 1
Not yet recruiting	`NCT03683953` - The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells	Phase 1
Recruiting	`NCT05413226` - Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility	N/A
Recruiting	`NCT05112159` - Study of IPG1094 in Healthy Participants	Phase 1
Completed	`NCT04689035` - A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144	Phase 1
Completed	`NCT04335045` - Phase I Study of PH100 (Ecklonia Cava Phlorotannins)	Phase 1
Completed	`NCT05037227` - Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Recruiting	`NCT05517291` - DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease	N/A
Recruiting	`NCT04573049` - The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement	Phase 4
Completed	`NCT05585463` - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Completed	`NCT04188821` - Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander	N/A
Completed	`NCT03667430` - Safety Evaluation of Porous Silica in Men	N/A
Completed	`NCT04499482` - Safety and Tolerability of Soy Fiber	N/A
Completed	`NCT03141905` - Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease	N/A
Completed	`NCT05244161` - A Quasi-experimental Evaluation of the Malezi Program in Tanzania	N/A
Recruiting	`NCT03791372` - Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy	Phase 1
Withdrawn	`NCT04759066` - The HEALiX™ Intubated Patient (IP) Pilot Study	N/A
Not yet recruiting	`NCT04774900` - Standardization of Ambulance Equipment
Active, not recruiting	`NCT04690725` - TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.