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Cytokine
Sargramostim for Parkinson's Disease
Phase 1
Waitlist Available
Led By Howard E Gendelman, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 months during the course of treatment, up to 48 weeks until drug cessation
Awards & highlights
Study Summary
This trial will study the safety and potential benefits of a 48-week treatment to improve motor control and mobility in people with Parkinson's.
Who is the study for?
This trial is for people aged 35-85 with Parkinson's Disease (PD) who've had symptoms like slow movement, tremors or stiffness for at least 3 years and are not beyond stage 4 on the Hoehn and Yahr scale. They must be able to get pregnant but agree to avoid it during the study. Excluded are those with other neurological disorders, certain medical treatments or conditions, allergies to yeast products, recent flu shots, substance abuse issues, or previous GM-CSF therapy.Check my eligibility
What is being tested?
The trial tests Sargramostim (Leukine), given as a weight-based dose over a period of 48 weeks. It aims to extend prior biomarker evaluations from an earlier study by observing clinical signs through well-being assessments and blood tests. The impact on motor control and mobility will also be measured using UPDRS scores both off treatment and while receiving Leukine.See study design
What are the potential side effects?
Potential side effects include immune system reactions due to stimulation by Sargramostim which could lead to inflammation in various organs. There may also be risks associated with leukapheresis (a procedure that separates white blood cells), such as bleeding or bruising at the needle site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 months during the course of treatment, up to 48 weeks until drug cessation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 months during the course of treatment, up to 48 weeks until drug cessation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in incidence of adverse events over time
Secondary outcome measures
Change in Treatment Biomarkers over time
Side effects data
From 2021 Phase 4 trial • 87 Patients • NCT0432692022%
Infectious disorder (not COVID-19)
15%
Constipation
7%
Cardiac disorder
5%
Epistaxis
2%
Pneumonia
2%
Thormboembolic event
2%
Aspergillus infection
2%
Respiratory failure
2%
Hypoxia
2%
Multi-bacterial bacteremia causing hemorrhagic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Active Sargramostim Treatment Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Leukine TreatmentExperimental Treatment1 Intervention
48 week 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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
2008
Completed Phase 4
~850
Find a Location
Who is running the clinical trial?
Partner Therapeutics, Inc.Industry Sponsor
6 Previous Clinical Trials
890 Total Patients Enrolled
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,723 Total Patients Enrolled
Howard E Gendelman, MDPrincipal InvestigatorUniversity of Nebraska
1 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- More than one of my blood relatives has been diagnosed with Parkinson's disease.I have no neurological issues other than Parkinson's disease.I got a flu shot in the last 3 weeks.My movement symptoms are getting worse.I was diagnosed with my condition between the ages of 35 and 85.I have had Parkinson's disease symptoms for 3 years or more.I have been treated with GM-CSF for immune system modulation.My doctor considers my autoimmune or inflammatory disorder significant.I am not pregnant and follow the required birth control measures.I am currently taking medication for a psychiatric disorder.I have a blood disorder or a bleeding/clotting issue.I haven't had immune system treatments in the last 90 days.I have slow movements and experience tremors or stiffness.I have had significant walking difficulties within 5 years of my diagnosis.I have difficulty with blood draws or IV access.I have had encephalitis before.I am currently taking lithium.My symptoms started more on one side of my body.My condition shows signs of a Parkinson-Plus disorder.I have had brain surgery for Parkinson's disease.My condition is stage 4 or less on the Hoehn and Yahr scale.My Parkinson's symptoms have only affected one side of my body for over 3 years.I do not have any serious illnesses that could affect my participation in the study.I was on neuroleptic medication when my Parkinson's symptoms started.I have had multiple strokes leading to gradually worsening Parkinson-like symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Leukine Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration officially sanctioned Leukine Treatment?
"While limited clinical data exists to suggest efficacy and safety, Leukine Treatment received a score of 1 on our assessment scale."
Answered by AI
Are there still opportunities for participants in this scientific experiment?
"According to clinicaltrials.gov, this medical trial appears to have suspended recruitment activities; the original posting was made on January 1st 2023 and it had its last update on December 22nd 2022. However, there are presently 472 other studies actively recruiting participants."
Answered by AI
Are individuals aged fifty and older able to join this experiment?
"In order to be accepted for this clinical study, applicants must meet the age requirement of 35-85 years old. Additionally, there are 25 trials that accept participants aged 18 and under, as well as 469 studies open to those over 65."
Answered by AI
What are the criteria for inclusion in this investigation?
"This clinical trial seeks 10 participants with a diagnosis of Parkinson's disease that are between the ages 35 and 85. Necessary criteria for enrolment include: onset of bradykinesia plus either rest tremor and/or rigidity, asymmetric motor symptom presentation, progressive condition state, symptoms persisting more than three years in duration; non-pregnant & not breastfeeding nor planning to become pregnant during the course of study if they possess childbearing capacity - must use effective contraception until end of trial; validated serum β-HCG test (if applicable); Hoehn and Yahr stage 4 or below."
Answered by AI
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