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NCT01398748 · ClinicalTrials.gov registry record · Phase 1
Intranasal Glutathione in Parkinson's Disease
A Phase 1 study, sponsored by Bastyr University.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01398748: Completed Phase 1 study, sponsored by Bastyr University.
NCT01398748 is a Phase 1 study that has completed, run by Bastyr University. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01398748, a Phase 1 study, has completed, sponsored by Bastyr University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles surrounding currently employed delivery methods have hindered the clinical utility of this therapy. Intranasal GSH, (in)GSH, is a novel method of delivery for this popular CAM therapy in patients with PD, and bypasses the obstacles associated with other delivery methods. It has been used in clinical practice since 2005. The aim of this study is to evaluate safety, tolerability, and preliminary absorption data of (in)GSH in volunteers with PD in a Phase I single ascending dose escalation study.
Primary Outcome
1a. Laboratory monitoring for adverse events will include CBC, ALT, AST, BUN, creatinine, uric acid, and urinalysis. Data will be collected throughout the 12-week intervention and at 1-mo following cessation of the study medication. 1b. Clinical adverse events will be measured using a daily patient diary and record score cards specifically screening for sinus irritation. Monitoring of Side Effects System (MOSES) will be used to screen for systemic and generalized adverse events. 1c. Effect on
Interventions
- DRUG Intranasal glutathione - (in)GSH
- DRUG Saline Intranasal Delivery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT01398748 record still lists
NCT01398748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Intranasal glutathione - (in)GSH is the first listed.
NCT01398748 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01398748 about?
NCT01398748 is a clinical study titled "Intranasal Glutathione in Parkinson's Disease". Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest t...
What is the current status of trial NCT01398748?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-07. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01398748?
The interventions under investigation include: Intranasal glutathione - (in)GSH (DRUG), Saline Intranasal Delivery (DRUG).
Who is sponsoring clinical trial NCT01398748?
This trial is sponsored by Bastyr University, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01398748's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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