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NCT01882010 · ClinicalTrials.gov registry record · Phase 1
Leukine (Sargramostim) for Parkinson's Disease
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01882010 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 37 participants.
The verdict
NCT01882010, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if Leukine (sargramostim) can be safely administered to Parkinson's disease patients for an extended period of time (56 days) and restore immune deficits seen in Parkinson's patients compared to controls. The development of magnetoencephalography (MEG) as a monitoring tool for PD will also be explored. At enrollment and repeating again at two 4-week intervals, whole blood from PD patients and controls will be obtained for analyses and the results will be used to calculate immune response profiles as a baseline for comparison after drug treatment. Physical examinations and motor assessments will also be performed on PD patients. After the 8-week baseline data collection, control participation will end and drug treatment of PD patients will begin. PD patients will be randomized, and half will receive drug and half will receive placebo. Leukine at a dosage of 6 µg/kg or saline as placebo will be administered by subcutaneous injection daily for 56 days (8 weeks). During drug treatment, PD patients will be monitored every two weeks by physical examinations, motor assessments, and blood analyses. As follow-up, four weeks after drug administration has stopped, subjects will again have physical examinations, motor assessments, and blood analyses. MEG will be performed on PD patients and controls at the start of drug treatment, and on PD patients at the end of the drug treatment period and 4 weeks after drug is stopped. In addtion, at the second cohort of 8 PD subjects, we will evaluate the potential Leukine-induced motor control and mobility improvements. Also, levels of the neurotransmitters glutamate, glutamine, serotonin, acetylcholine, GABA, norepinephrine and epinephrine in serum/plasma will be analyzed to correlate with changes in motor function and drug treatment.
Interventions
- DRUG placebo
- DRUG sargramostim
- DIAGNOSTIC_TEST Sham Comparator: Controls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2013-09-01 |
| Est. Completion | 2016-01-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01882010
The ClinicalTrials.gov registry entry for NCT01882010 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 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 3 interventions - of which placebo is the first listed.
NCT01882010 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01882010 about?
NCT01882010 is a clinical study titled "Leukine (Sargramostim) for Parkinson's Disease". The purpose of this study is to determine if Leukine (sargramostim) can be safely administered to Parkinson's disease patients for an extended period of time (56 days) and restore immune deficits seen in Parkinson's patients compared to controls. The development of magnetoencephalography (MEG) as a ...
What is the current status of trial NCT01882010?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2013-09-01. Estimated completion is 2016-01-01.
What interventions are being tested in trial NCT01882010?
The interventions under investigation include: placebo (DRUG), sargramostim (DRUG), Sham Comparator: Controls (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT01882010?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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