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Cytokine

GM-CSF for Myasthenia Gravis

Phase < 1
Waitlist Available
Led By Matthew N Meriggioli, MD
Research Sponsored by Muscular Dystrophy Association
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 150 days
Awards & highlights

Study Summary

The purpose of this study is to determine whether the drug Leukine (GM-CFS) is safe and tolerated by patients with autoimmune myasthenia gravis (MG).

Eligible Conditions
  • Myasthenia Gravis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~150 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 150 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of GM-CSF in patients with myasthenia gravis
The change from baseline in the quantitative and functional (suppressive capacity) characterization of circulating regulatory T cells at 120 days post-treatment
The change from baseline in the quantitative and functional (suppressive capacity) characterization of circulating regulatory T cells at 30 days post-treatment
+1 more
Secondary outcome measures
Change from baseline in Manual Muscle Testing (MMT) score at day 120
Change from baseline in Manual Muscle Testing (MMT) score at day 60
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at day 120
+11 more

Side effects data

From 2014 Phase 1 & 2 trial • 28 Patients • NCT01592045
100%
Pyrexia
93%
Hypokalemia
85%
Hypoalbuminemia
78%
Hyponatremia
67%
Alanine Aminotransferase Increased
63%
Pruritus
59%
Pain
56%
Hypocalcemia
56%
Anemia
52%
Aspartate Aminotransferase Increased
48%
Abdominal Pain
48%
Cough
44%
Hypertriglyceridemia
44%
Hypotension
44%
Platelet Count Decreased
41%
Tachycardia
41%
Neutrophil Count Decreased
37%
Face Odema
37%
Diarrhea
37%
Vomiting
37%
Hyperglycemia
33%
Pain in Extremity
33%
Nausea
30%
Hypomagnesemia
30%
Urticaria
26%
Sinus Tachycardia
26%
Urinary Retention
26%
Hypertension
26%
Rash
22%
Capillary Leak Syndrome
22%
Blood Bilirubin Increased
22%
Hypercalcemia
22%
Decreased Appetite
22%
White Blood Cell Count Decreased
22%
Dry Skin
19%
Hypophosphatemia
19%
Hypoxia
19%
Irritability
19%
Urine Output Decreased
19%
Hypoglycemia
19%
Fatigue
15%
Hyperkalemia
15%
Back Pain
15%
Device Related Infection
15%
Contusion
15%
Periorbital Edema
15%
Headache
15%
International Normalized Ratio Increased
15%
Constipation
15%
Edema Peripheral
15%
Agitation
11%
Activated Partial Thromboplastin Time Prolonged
11%
Chills
11%
Weight Increased
11%
Proteinuria
11%
Tachypnea
11%
Malaise
11%
Edema
11%
Injection Site Reaction
11%
Blood Creatinine Increased
11%
Fluid Retention
11%
Rash Maculo-Papular
11%
Hyperbilirubinemia
7%
Weight Decreased
7%
Anxiety
7%
Electrocardiogram QT Prolonged
7%
Neutropenia
7%
Gastritis
7%
Gamma-Glutamyltransferase Increased
7%
Clostridium Difficile Infection
7%
Blood Alkaline Phosphatase Increased
7%
Eosinophil Count Increased
7%
Rhinorrea
7%
Flushing
7%
Abdominal Distension
7%
Hypersensitivity
7%
Lip Swelling
7%
Gastroenteritis Viral
7%
Lymphocyte Count Decreased
7%
Oropharyngeal Pain
7%
Asthenia
7%
Generalized Edema
7%
Blood Triglycerides Increased
7%
Hematuria
7%
Neck Pain
7%
Musculoskeletal Pain
7%
Abnormal Behavior
7%
Dysuria
4%
Restlessness
4%
Blood Chloride Increased
4%
Enterobacter Sepsis
4%
Cheilitis
4%
Convulsion
4%
Mydriasis
4%
Disease Progression
4%
Streptococcal Bacteremia
4%
Nasal Congestion
4%
Insomnia
4%
Sepsis
4%
Alpha Hemolytic Stretococcal Infection
4%
Bacteremia
4%
Renal Failure Acute
4%
Localized Edema
4%
Lethargy
4%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
UTC ch14.18
NCI ch14.18

Trial Design

1Treatment groups
Experimental Treatment
Group I: GM-CSFExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
FDA approved

Find a Location

Who is running the clinical trial?

Muscular Dystrophy AssociationLead Sponsor
36 Previous Clinical Trials
60,419 Total Patients Enrolled
Matthew N Meriggioli, MDPrincipal InvestigatorUniversity of Illinois at Chicago, 912 S. Wood St., Rm 855-N, M/C 796, Chicago IL 60612

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Generalized Myasthenia Gravis
Matthew N. Meriggioli, MD 2012. "A Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01555580.
All > Myasthenia Gravis
~1 spots leftby Apr 2025
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