Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease (NOPARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03568968
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:

NOPARK is a double-blinded randomized controlled trial that studies nicotinamide supplementation in early Parkinson's disease.

Parkinson's disease (PD) is a major cause of death and disability and has a worldwide socioeconomic impact. It affects ~2% of the population above the age of 65 years and its prevalence increases dramatically as the population ages. The etiology and molecular pathogenesis underlying PD remain unknown. Recent evidence has implicated an impaired neuronal metabolism due to mitochondrial dysfunction, in particular NAD-deficiency is a key-event in the pathogenesis of PD. We propose that in order to correct this metabolic defect and treat PD, we need to boost neuronal NAD levels. This would improve mitochondrial function and could slow PD progression. Nicotinamide riboside is a precursor NAD vitamin. In this study we will investigate if nicotinamide riboside supplementation will correct NAD deficiency and thereby slow progression of PD symptoms. This study will recruit 200 patients with newly diagnosed PD and randomly assign them in an 1:1 ratio to either nicotinamide riboside or placebo administration for 52 weeks. During this trial the investigators will determine if nicotinamide riboside delays PD disease progression measured by clinical monitoring tools (MDS-UPDRS). Patients receiving nicotinamide riboside supplementation will receive a daily dose of 1000mg for the duration of the trial. This trial will also collect biological material from participants to see if nicotinamide riboside supplementation rectifies NAD deficiency and metabolism deficiencies.


Condition or disease Intervention/treatment Phase
Parkinson Disease Dietary Supplement: Nicotinamide Riboside Drug: Placebo Not Applicable

Detailed Description:
Individuals with PD (n = 200) will be recruited starting 01/09/2019. Newly diagnosed and/or treatment naïve patients will be given Selegiline 10 mg/day PO and Sinemet 100 x 3. Treatment efficacy will be assessed upon reexamination every 1 month. If adequate symptomatic relief is not achieved, the dopaminergic therapy may be increased by 150 mg levodopa until optimal effect or a maximum dose of Sinemet 200 x 3. If adequate symptomatic relief is not achieved on this dose, the patient will excluded and further followed-up at the regular outpatient service. Once optimal effect is reached (i.e. stable treatment for at least 3 months, the regime will be frozen for the duration of the study period (52 weeks). Patients will then be randomized to receive either Nicotamide riboside or placebo. Both the participants and the investigators are masked. The trial will have a 52 weeks (1 year) exposure period, during which patients will self-administer NR 500 mg x 2/day, or placebo per os. In addition, all patients will take a stable regime of selegiline 10 mg/day plus optimal dopaminergic therapy. After the baseline visit, participants will be reassessed at 4, 13, 26, 39 and 52 weeks in person. Clinical evaluation will be performed by one of the neurologists involved in the study and/or the study nurse. The primary outcome of the study is the total score of the Movement disorder society Unified parkinson's disease rating scale (MDS-UPDRS) comparing the NR and and placebo group.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double-blinded study. 200 Participants randomized in 1:1 ratio to either vitamine supplementation or placebo.
Masking: Double (Participant, Investigator)
Masking Description: Both patients and all investigators are blinded during the trial and during data analysis.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease: the NOPARK Study
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotinamide Riboside
nicotinamide riboside, 1000mg daily for the duration of the trial (52 weeks). Dosage form is tablets.
Dietary Supplement: Nicotinamide Riboside
1000mg one time daily. Given as tablets. Duration of the trial, 52 weeks.

Placebo Comparator: Placebo Comparator
Placebo tablets, no active ingredients.
Drug: Placebo
Placebo drug, given 1 time daily for the duration of the trial; 52 weeks.




Primary Outcome Measures :
  1. MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale) [ Time Frame: 52 weeks ]
    Clinical rating scale approved by mobement disorder society. The Movement Disorder Society Unified Parkinson's Disease rating Scale (MDS-UPDRS) measures multiple clinical disabilities on a scale of 1-4. The subscores are summed providing a total score for MDS-UPDRS. The total score ranges from 0 to 260. Higher score indicates worse outcome.


Secondary Outcome Measures :
  1. NAD metabolism [ Time Frame: 52 weeks ]
    Levels of metabolites in the NAD metabolites measured from biological material (blood).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for Parkinson's disease.
  2. Positive [¹²³I]FP-CIT single photon emission CT (DaTscan) confirming nigrostriatal degeneration
  3. Diagnosed within one year from enrolment
  4. Hoehn and Yahr score <= 2 at enrolment
  5. Optimal symptomatic therapy, not requiring adjustments, for at least 3 months

Exclusion Criteria:

  1. Dementia or other neurological disorder at baseline visit
  2. Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit
  3. Prior use of dopaminergic treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568968


Contacts
Layout table for location contacts
Contact: Charalampos Tzoulis, MD, PhD 94392305 ext +47 charalampos.tzoulis@helse-bergen.no
Contact: Brage Brakedal, MD 99777962 ext +47 bragebrakedal@gmail.com

Sponsors and Collaborators
Haukeland University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Charalampos Tzoulis, MD, PhD Haukeland University Hospital

Layout table for additonal information
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03568968     History of Changes
Other Study ID Numbers: 2017/2083
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
Parkinson's Disease
NAD metabolism
Mitochondria
Nicotinamide Riboside

Additional relevant MeSH terms:
Layout table for MeSH terms
Niacinamide
Niacin
Nicotinic Acids
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents