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NCT01427517 · ClinicalTrials.gov registry record · Phase 1
Intravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's Disease
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01427517: Completed Phase 1 study, sponsored by University of Minnesota.
NCT01427517 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01427517, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The investigators are interested in determining if the investigators are able to detect changes in brain chemistry using Magnetic Resonance Spectroscopy (MRS) in individuals with Parkinson's disease (PD), those with Gaucher's disease (GD), and those without neurological disorders (healthy controls) when they are given the antioxidant N-acetylcysteine (NAC). This study will combine information from a medical history, a physical examination and disease rating scales with results obtained using MRS brain scans and pharmacokinetic studies from blood samples. This research will require 1 visit that will require about 4 to 5 hours of time. During this study, participants will provide their medical history, be examined and undergo a rating scale for about one hour; the brain scan and pharmacokinetic studies will require 1.5-2 hours of time; in total the study will take about 4-5 hours.
Primary Outcome
change in brain GSH levels from baseline to post-NAC administration (90 - 110 minutes) in all subjects
Interventions
- DRUG N-acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01427517 record still lists
NCT01427517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which N-acetylcysteine is the first listed.
NCT01427517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01427517 about?
NCT01427517 is a clinical study titled "Intravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's Disease". The investigators are interested in determining if the investigators are able to detect changes in brain chemistry using Magnetic Resonance Spectroscopy (MRS) in individuals with Parkinson's disease (PD), those with Gaucher's disease (GD), and those without neurological disorders (healthy controls) ...
What is the current status of trial NCT01427517?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-07. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01427517?
The interventions under investigation include: N-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT01427517?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01427517's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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