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NCT05677633 · ClinicalTrials.gov registry record · Phase 1
Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT05677633 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 11 participants.
The verdict
NCT05677633, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Investigators will evaluate the safety of a 48 week regimen of Leukine administered as a weight-based dose at 3 ug/kg/ day for 5 days followed by a 2-day holiday. This 48 week long study will extend the prior biomarker evaluations observed in a previous study. Clinical signs and symptoms will be measured by personal well-being, physical, and neurological examinations (UPDRS Parts I, II, III, and IV assessments) and blood tests (CBC with differential, total T cell count, and a comprehensive metabolic sera panel). Leukapheresis will be performed to collect large numbers of immune cells for biomarker testing and immune phenotyping. Additionally, the investigators will determine whether immune deficits of PD are consistent during baseline data collection, and the potential Leukine-induced motor control and mobility improvements will be determined by UPDRS part I, II, III, and IV scores off treatment and on treatment.
Interventions
- DRUG Sargramostim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2023-01-19 |
| Est. Completion | 2024-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05677633
The ClinicalTrials.gov registry entry for NCT05677633 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sargramostim is the first listed.
NCT05677633 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05677633 about?
NCT05677633 is a clinical study titled "Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease". Investigators will evaluate the safety of a 48 week regimen of Leukine administered as a weight-based dose at 3 ug/kg/ day for 5 days followed by a 2-day holiday. This 48 week long study will extend the prior biomarker evaluations observed in a previous study. Clinical signs and symptoms will be mea...
What is the current status of trial NCT05677633?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2023-01-19. Estimated completion is 2024-11-01.
What interventions are being tested in trial NCT05677633?
The interventions under investigation include: Sargramostim (DRUG).
Who is sponsoring clinical trial NCT05677633?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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