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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 April 2024 |
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Main ID: |
NCT03568968 |
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Date of registration:
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14/06/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized Controlled Trial of Nicotinamide Riboside Supplementation in Early Parkinson's Disease
NOPARK |
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Scientific title:
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A Randomized Controlled Trial of Nicotinamide Riboside Supplementation in Early Parkinson's Disease: the NOPARK Study |
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Date of first enrolment:
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May 15, 2020 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03568968 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Norway
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Contacts
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Name:
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Charalampos Tzoulis, MD, PhD |
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Address:
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Telephone:
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94392305 |
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Email:
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charalampos.tzoulis@helse-bergen.no |
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Affiliation:
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Name:
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Charalampos Tzoulis, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Haukeland University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic
criteria for Parkinson's disease
- [¹²³I]FP-CIT single photon emission CT (DaTscan) confirming nigrostriatal degeneration
- Diagnosed with PD within 2 years from enrolment
- Hoehn and Yahr score < 3 at enrolment
- Optimal symptomatic therapy, not requiring adjustments, for at least 1 month.
- Age equal to or greater than 35 years at time of enrolment.
Exclusion Criteria:
- Dementia or other neurodegenerative disorder at baseline visit
- Diagnosed with atypical parkinsonism or vascular parkinsonism
- Any psychiatric disorder that would interfere with compliance in the study.
- Any severe somatic illness that would make the individual unable to comply and
participate in the study.
- Use of high dose vitamin B3 supplementation within 30 days of enrolment
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at
baseline visit.
- Genetically confirmed mitochondrial disease
Age minimum:
35 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Other: Placebo
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Dietary Supplement: Nicotinamide Riboside
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Primary Outcome(s)
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Disease severity assessed by the total MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale) subsections I-III
[Time Frame: 52 weeks]
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Secondary Outcome(s)
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Change in the clinical severity of non-motor symptoms assessed by the Non-Motor Symptoms Assessment Scale
[Time Frame: 52 weeks]
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Change in quality of life assessed by the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire.
[Time Frame: 52 weeks]
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Change in the clinical severity of cognitive decline assessed by the Montreal Cognitive Assessment (MoCA) scale
[Time Frame: 52 weeks]
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Change in the severity of nigrostriatal degeneration assessed by [¹²³I]FP-CIT single photon emission CT (DaTscan)
[Time Frame: 52 weeks]
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Secondary ID(s)
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2017/2083
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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