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Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02212678
Recruitment Status : Completed
First Posted : August 8, 2014
Results First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Parkinson's Disease Society of the United Kingdom
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE August 4, 2014
First Posted Date  ICMJE August 8, 2014
Results First Submitted Date  ICMJE April 23, 2019
Results First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 16, 2019
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Glutathione (GSH) Brain Levels [ Time Frame: pre-dose and after approximately 28 days of treatment ]
GSH levels in brain of all subjects at baseline and post-NAC (n-acetylcysteine) dosing as measured by magnetic resonance spectroscopy (MRS)
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
GSH brain levels [ Time Frame: pre-dose and after approximately 28 days of treatment ]
GSH levels in brain of all subjects at baseline and post-NAC dosing as measured by MRS
Change History Complete list of historical versions of study NCT02212678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
  • NAC clearance [ Time Frame: 8 hours after NAC dosing ]
    NAC concentrations will be measured prior to and after dosing to estimate NAC clearance
  • GSH and GSH redox blood levels [ Time Frame: predose and after approximately 28 days of dosing ]
    GSH and GSH redox measurements will be made prior to dosing and after approximately 28 days of dosing
  • NAC volume of distribution [ Time Frame: over 8 hrs after dosing ]
    NAC concentrations will be measured prior to and after dosing to estimate NAC volume of distribution
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
Official Title  ICMJE Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
Brief Summary The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.
Detailed Description The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry. The investigators' hypothesis is that repeated oral dosing of NAC will result in increased brain and red blood cell GSH concentrations in individuals with Parkinson's disease (PD) and healthy controls. The specific aims are to 1.) measure plasma and blood (red blood cell) glutathione (GSH) and ratio of reduced GSH to oxidized glutathione (GSSG) in individuals with PD and healthy controls at baseline and after four weeks of repeated high doses of oral NAC (6000 mg/day) and 2) measure cortical GSH levels (as ascertained through MRS) in those with PD and healthy controls at baseline and four weeks during repeated high doses of oral NAC (6000 mg/day) simultaneously with Aim 1. This study will combine information from a medical history, a physical examination, and disease rating scales with results obtained using Magnetic Resonance Spectroscopy (MRS) brain scans and pharmacokinetic studies from blood samples. This research will require 2 visits, one at baseline and one after approximately 28 days of therapy. Participants will provide their medical history during the first visit, and undergo a physical examination and rating scale each visit (duration: 1 hour). The first visit including the brain scans and blood collection will require approximately 3 hours of time. The brain scan and pharmacokinetic studies for the second visit will require approximately 8 hours of time. In total the second visit will take roughly 9 hours.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Drug: N-acetylcysteine capsule
N-acetylcysteine capsule
Other Name: NAC
Study Arms  ICMJE Experimental: N-acetylcysteine
Subjects will be provided 6000 mg/day of N-acetylcysteine (capsule) to be divided into 2 equal daily doses and taken orally for approximately 28 days
Intervention: Drug: N-acetylcysteine capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2014)
9
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All participants must be 18 years or older
  2. All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent
  3. Individuals with medically stable Parkinson's disease (in the opinion of the investigator)
  4. All participants must not have taken antioxidants NAC, glutathione, coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study
  5. Absence of dementia in all subjects

Exclusion Criteria:

  1. Inability to undergo MRI scanning without sedation and other MRI counterindications, such as metal in the body (see section 7.3)
  2. Medically unstable conditions as determined by the investigators
  3. Pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception
  4. Diagnosis of asthma that is presently being treated with any medication, or past history of asthma/bronchospasm resulting in an emergency room visit, hospitalization or treatment
  5. Unable to adhere to study protocol for whatever reason
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02212678
Other Study ID Numbers  ICMJE 1406M51207
123269 ( Other Identifier: FDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Parkinson's Disease Society of the United Kingdom
Investigators  ICMJE
Principal Investigator: Paul Tuite, MD University of Minnesota
Principal Investigator: Lisa Coles, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP