Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03790670 · ClinicalTrials.gov registry record · Phase 1
Biomarker Assessments of Leukine During Treatment of Parkinson's Disease
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03790670 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 7 participants.
The verdict
NCT03790670, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
First, the investigators will determine the safety of a 36 month regimen of Leukine administered as a weight-based dose at 3 µg/kg/day for 5 days (week), followed by a 2-day holiday (weekend). This 36 month (n=10) pilot study will extend the prior 2 month observation tests towards the goal of assessing the safety of Leukine for treatment of Parkinson's disease (PD). 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). Second, we will assess regimen tolerability administered in a dose reduction, from 6 µg/kg/day without interruption, to 3 µg/kg/day with 2 day drug holidays. The investigators will examine over a time of 36 months, effects of treatment on defined adaptive immune deficits in PD as measured by analysis of peripheral blood mononuclear cells collected before, during, and after cessation of Leukine administration. Individual T cell parameters will be assessed and will include links between T cell function and subset analyses and clinical neurological signs and symptoms. In addition, the functional stability of the immune deficits will be assess in PD by examining T cell subsets in PD patients in this study against prior results. The investigators will also determine whether the 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 | 7 participants |
| Start Date | 2019-01-30 |
| Est. Completion | 2024-10-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03790670
The ClinicalTrials.gov registry entry for NCT03790670 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 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.
NCT03790670 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03790670 about?
NCT03790670 is a clinical study titled "Biomarker Assessments of Leukine During Treatment of Parkinson's Disease". First, the investigators will determine the safety of a 36 month regimen of Leukine administered as a weight-based dose at 3 µg/kg/day for 5 days (week), followed by a 2-day holiday (weekend). This 36 month (n=10) pilot study will extend the prior 2 month observation tests towards the goal of assess...
What is the current status of trial NCT03790670?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2019-01-30. Estimated completion is 2024-10-01.
What interventions are being tested in trial NCT03790670?
The interventions under investigation include: sargramostim (DRUG).
Who is sponsoring clinical trial NCT03790670?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.