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Cytokine

Leukine for Parkinson's Disease

Phase 1

Waitlist Available

Led By Howard 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

Age at onset 35-85 years

Must be stage 4 or less according to the Hoehn and Yahr scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months of treatment, followed by 1 month drug cessation

Awards & highlights

Study Summary

This trial is testing the safety of a 24-month regimen of Leukine as a treatment for Parkinson's disease. Clinical signs and symptoms will be measured by personal well-being, physical, and neurological examinations, and blood tests. The investigators will also assess the tolerability of the regimen and the effects of treatment on immune deficits in PD.

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 shouldn't have other disorders that look like PD, be on certain medications, have a history of brain surgery for PD, autoimmune diseases, recent immunotherapy treatments, known allergies to GM-CSF or yeast products, substance abuse issues or any serious illnesses that could affect their participation.Check my eligibility

What is being tested?

The study tests Leukine (sargramostim), given as an injection at a dose of 3 µg/kg/day for five days with two-day breaks over three years. It aims to check if it's safe long-term and whether it can improve motor control in PD by monitoring clinical signs/symptoms through exams and blood tests. The trial also looks into how Leukine affects immune function related to PD.See study design

What are the potential side effects?

Potential side effects from Leukine may include reactions at the injection site such as redness or pain; general body discomforts like fatigue; possible changes in blood counts leading to increased infection risk; and possibly inflammation-related symptoms due to its action on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 35 and 85 years old.

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My condition is stage 4 or less on the Hoehn and Yahr scale.

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I have had Parkinson's disease symptoms for 3 years or more.

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My symptoms started more on one side of my body.

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I have slow movements and either rest tremor or stiffness.

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My muscle control or movement is getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months of treatment, followed by 1 month drug cessation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months of treatment, followed by 1 month drug cessation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months of treatment, followed by 1 month drug cessation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Associated Adverse Events

Secondary outcome measures

Determination of Immune Cell Function

Determination of Immune Cell Number

Determination of Immune Cell Phenotype

Side effects data

From 2011 Phase 3 trial • 170 Patients • NCT00002766

17%

Fatigue

16%

Hypokalemia

15%

Febrile neutropenia

15%

Hypophosphatemia

13%

Pain, other

13%

Abdominal pain/cramping

11%

Stomatitis/pharyngitis

Thrombosis

Dyspnea

Hypomagnesemia

Dizziness

Bilirubin

Prothrombin Time

Vision-blurred vision

SGPT (ALT)

Hyponatremia

Ileus (or neuroconstipation)

Anorexia

Infection/Febrible Neutrophil-Other

Hemorrhage, other

Platelets

Neuropathy-motor

infection

Pulmonary, other

Renal failure

Dehydration

Adult respiratory disorder

Diarrhea

Gastrointestinal, other

Epistaxis

Constipation

Leukocytes

Dermatology, skin other

Neutrophils (Leukemia)

Chest pain

Syncope

Supraventricular tachycardia

Headache

disseminated intravascular coagulation

Cardiovascular, Arrhythmia other

Ascites

ALT, SGPT

Pancreatitis

Supravent arrhythmia

Neutrophils

100%

80%

60%

40%

20%

Study treatment Arm

L-20

All-2

Trial Design

1Treatment groups

Experimental Treatment

Group I: Leukine TreatmentExperimental Treatment1 Intervention

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sargramostim

FDA approved

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

536 Previous Clinical Trials

1,143,915 Total Patients Enrolled

Howard Gendelman, MDPrincipal Investigator - University of Nebraska

University of Nebraska

Media Library

Sargramostim (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT03790670 — Phase 1

Parkinson's Disease Research Study Groups: Leukine Treatment

Parkinson's Disease Clinical Trial 2023: Sargramostim Highlights & Side Effects. Trial Name: NCT03790670 — Phase 1

Sargramostim (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03790670 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots remaining for participants in this experiment?

"This research is no longer enrolling patients. It was initially posted on January 30th 2019 and last edited October 19th 2022. Currently, there are 485 trials looking for participants with Parkinson's disease and 43 studies recruiting participants to test sargramostim as a treatment option."

Answered by AI

To whom is participation in this trial open?

"For this medical trial, 7 individuals diagnosed with Parkinson's disease and aged between 35 to 85 are being admitted. To be qualified for the research, participants must have had PD symptoms for three years or longer; demonstrate asymmetric onset of clinical signs; experience bradykinesia, tremor, and/or rigidity associated with their condition; remain at stage 4 or less according to the Hoehn & Yahr scale; not be expecting a child before its completion."

Answered by AI

What indications is sargramostim most commonly prescribed to treat?

"Sargramostim is a viable treatment for severe infections, lymphoma, Hodgkin's disease and even bone marrow transplants."

Answered by AI

Are there any age restrictions on enrollment for this trial?

"According to the trial's requirements, individuals between 35 and 85 years old may be eligible for entry. There are 37 studies open to people below 18 and 516 research opportunities available to those above 65."

Answered by AI

Are there any extant studies which have employed sargramostim?

"Currently, there are 43 different research studies occurring involving sargramostim. 5 of these trials have advanced to Phase 3 status. While the vast majority of these investigations are taking place in Seattle, Washington, 1888 other sites around the world offer this potential therapy as well."

Answered by AI

Has the FDA recognized sargramostim as a legitimate therapeutic treatment?

"Due to its Phase 1 designation, our experts at Power rated sargramostim a 1 in terms of safety as there is only limited data available on the drug's efficacy and security."

Answered by AI

What is the uppermost capacity of individuals participating in this clinical exploration?

"Unfortunately, this medical trial has concluded its enrollment period. Initially posted on January 30th 2019 and last updated October 19th 2022, it is no longer searching for patients. However, there are currently 485 studies recruiting patients with Parkinson's disease and 43 trials enrolling participants to study sargramostim."

Answered by AI

Recent research and studies

npj Parkinson's DiseaseJournal

Evaluation of the Safety and Immunomodulatory Effects of Sargramostim in a Randomized, Double-blind Phase 1 Clinical Parkinson’s Disease Trial

Gendelman, Howard E., Yuning Zhang, Pamela Santamaria, Katherine E. Olson, Charles R. Schutt, Danish Bhatti, Bhagya Laxmi Dyavar Shetty, et al.. 2017. “Evaluation of the Safety and Immunomodulatory Effects of Sargramostim in a Randomized, Double-blind Phase 1 Clinical Parkinson’s Disease Trial”. Npj Parkinson's Disease. Springer Science and Business Media LLC. doi:10.1038/s41531-017-0013-5.

Journal of Neuroimmune PharmacologyJournal

CD4+ Regulatory and Effector/memory T Cell Subsets Profile Motor Dysfunction in Parkinson’s Disease

Saunders, Jessica A. Hutter, Katherine A. Estes, Lisa M. Kosloski, Heather E. Allen, Kathryn M. Dempsey, Diego R. Torres-Russotto, Jane L. Meza, et al.. 2012. “CD4+ Regulatory and Effector/memory T Cell Subsets Profile Motor Dysfunction in Parkinson’s Disease”. Journal of Neuroimmune Pharmacology. Springer Science and Business Media LLC. doi:10.1007/s11481-012-9402-z.

Journal of NeuroimmunologyJournal

GM-CSF Induces Neuroprotective and Anti-inflammatory Responses in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine Intoxicated Mice

Kosloski, Lisa M., Elizabeth A. Kosmacek, Katherine E. Olson, R. Lee Mosley, and Howard E. Gendelman. 2013. “GM-CSF Induces Neuroprotective and Anti-inflammatory Responses in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine Intoxicated Mice”. Journal of Neuroimmunology. Elsevier BV. doi:10.1016/j.jneuroim.2013.10.009.

EBioMedicineJournal