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

• 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: University of Minnesota
• Collaborator: Parkinson's Disease Society of the United Kingdom
• Information provided by (Responsible Party): University of Minnesota

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Parkinson Disease
• Intervention: Drug: N-acetylcysteine capsule
• Enrollment: 8

Participant Flow

Recruitment Details
Pre-assignment Details

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

Baseline Characteristics

Arm/Group Title		N-acetylcysteine
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
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%

Outcome Measures

1. Primary Outcome

Title	Glutathione (GSH) Brain Levels
Description	GSH levels in brain of all subjects at baseline and post-NAC (n-acetylcysteine) dosing as measured by magnetic resonance spectroscopy (MRS)
Time Frame	pre-dose and after approximately 28 days of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-acetylcysteine
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 Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: mM
Baseline	0.93 (0.33)
Post-NAC	0.99 (0.35)

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	N-acetylcysteine
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%)
Serious Adverse Events
	N-acetylcysteine
	Affected / at Risk (%)
Total	0/8 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: durh0016@umn.edu

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02212678
• 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