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Eculizumab for Myasthenia Gravis
Study Summary
This trial is testing a new drug to see if it can help kids with a disease that causes muscle weakness.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2011 Phase 4 trial • 7 Patients • NCT00867932Trial Design
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- You have received treatment with PE within the 4 weeks before the first dose.You have received the vaccine for Neisseria meningitidis.Children who weigh less than 15 kilograms and are getting ongoing IVIg treatment.You have taken rituximab within the last 6 months before starting the trial.You have a thymoma that is not being treated, or you had thymic carcinoma or thymic malignancy in the past and it has not been treated successfully for at least 5 years.You have been treated with eculizumab or other drugs that block the complement system before.You have been classified as having moderate to severe symptoms of myasthenia gravis by a doctor.You had surgery to remove your thymus gland within the last year.You have been diagnosed with myasthenia gravis and have specific test results or have shown improvement with certain medications.You have myasthenia gravis (MG) that has not improved with at least one year of treatment, or you need plasma exchange or intravenous immunoglobulin to manage your symptoms, or your doctor believes that your MG is significantly affecting your daily life despite current treatment.If you're between 12-18 years old, your QMG total score must be 12 or higher at screening. If you're 6-11 years old, there's no minimum QMG score needed, but you must have documented weakness in at least one limb.
- Group 1: Eculizumab Intravenous (IV) Infusion
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this research project only open to people who are over the age of 55?
"Children aged 6 to 17 years old are being enrolled in this research project."
Who might be able to take part in this particular clinical research?
"This clinical trial is seeking 11 participants, aged 6 to 17, who have myasthenia gravis. In addition to this primary condition, patients must also: a) have tried one or more immunosuppressive therapies for at least a year with no success; b) require maintenance plasma exchange or intravenous immunoglobulin treatments to control symptoms; c) be significantly impacted by myasthenia gravis despite current treatment options; d) have a total score of 12 or higher on the Quantitative Myasthenia Gravis scale (for patients aged 12-18). Male and female pediatric participants are both eligible for this"
What other research is there on this topic?
"As of now, there are 14 ongoing studies being conducted for Eculizumab in 121 different cities and 42 countries. The first trial happened in 2016 and was completed by Alexion Pharmaceuticals. They studied 270 patients during Phase 3 of the drug approval process. 43 more studies have been done since then."
What other eculizumab studies have been completed and what were the results?
"Eculizumab was first studied in 2016 and, as of now, 43 trials have been completed. Out of the 14 ongoing studies, a significant amount are taking place in Akron, Ohio."
Has Eculizumab been cleared by the FDA?
"Eculizumab has been found to be safe in multiple trials and thus, it received a score of 3 on our safety scale."
What is the ceiling for potential participants in this research project?
"This specific study is no longer recruiting patients for the clinical trial. However, there are 87 other trials related to myasthenia gravis and 14 trials concerning Eculizumab that are currently looking for participants."
Why do most people take Eculizumab?
"Eculizumab is most commonly used to treat myasthenia gravis, but it can also help patients with neuromyelitis optica, paroxysmal nocturnal haemoglobinuria (pnh), and thyroid stimulating immunoglobulins."
Is this clinical trial limited to just a few hospitals in the United States?
"Akron Children's Hospital, Medical University of South carolina, and University of South Florida are some of the 18 sites where this trial is enrolling patients."
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