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

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. Read our disclaimer for details.
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 - Clinical and Translational Science Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson Disease
Intervention Drug: N-acetylcysteine capsule
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-acetylcysteine
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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

N-acetylcysteine capsule: N-acetylcysteine capsule

Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title N-acetylcysteine
Hide Arm/Group Description

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

N-acetylcysteine capsule: N-acetylcysteine capsule

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  25.0%
>=65 years
6
  75.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
71  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
 100.0%
1.Primary Outcome
Title Glutathione (GSH) Brain Levels
Time Frame pre-dose and after approximately 28 days of treatment
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine
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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

N-acetylcysteine capsule: N-acetylcysteine capsule

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: mM
Baseline 0.93  (0.33)
Post-NAC 0.99  (0.35)
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-acetylcysteine
Hide Arm/Group Description

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

N-acetylcysteine capsule: N-acetylcysteine capsule

All-Cause Mortality
N-acetylcysteine
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
N-acetylcysteine
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-acetylcysteine
Affected / at Risk (%)
Total   4/8 (50.00%) 
Gastrointestinal disorders   
indigestion *  4/8 (50.00%) 
Nervous system disorders   
increased tremor *  3/8 (37.50%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lisa Coles, MS, PhD
Organization: University of Minnesota
Phone: 4109264788
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02212678     History of Changes
Other Study ID Numbers: 1406M51207
123269 ( Other Identifier: FDA )
First Submitted: August 4, 2014
First Posted: August 8, 2014
Results First Submitted: April 23, 2019
Results First Posted: May 16, 2019
Last Update Posted: May 16, 2019