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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 is a Phase 1 study that has completed, run by Bastyr University. The registered enrollment target is 34 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01398748
The ClinicalTrials.gov registry entry for NCT01398748 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bastyr University, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intranasal glutathione - (in)GSH is the first listed.
NCT01398748 reports 0 study locations.
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.
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