Trial Outcomes & Findings for Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease (NCT NCT02212678)

Results Overview

GSH levels in brain of all subjects at baseline and post-NAC (n-acetylcysteine) dosing as measured by magnetic resonance spectroscopy (MRS)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

pre-dose and after approximately 28 days of treatment

Results posted on

2019-05-16

Participant milestones
Measure	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 N-acetylcysteine capsule: N-acetylcysteine capsule
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	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 N-acetylcysteine capsule: N-acetylcysteine capsule
Overall Study Adverse Event	1

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	N-acetylcysteine n=8 Participants 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
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=8 Participants
Age, Categorical >=65 years	6 Participants n=8 Participants
Age, Continuous	71 years STANDARD_DEVIATION 11 • n=8 Participants
Sex: Female, Male Female	4 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=8 Participants
Region of Enrollment United States	8 Participants n=8 Participants

Timeframe: 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)

Outcome measures
Measure	N-acetylcysteine n=7 Participants 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
Glutathione (GSH) Brain Levels Baseline	0.93 mM Standard Deviation 0.33
Glutathione (GSH) Brain Levels Post-NAC	0.99 mM Standard Deviation 0.35

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	N-acetylcysteine n=8 participants at risk 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
Gastrointestinal disorders indigestion	50.0% 4/8 • 6 weeks
Nervous system disorders increased tremor	37.5% 3/8 • 6 weeks

University of Minnesota

Phone: 4109264788