Your session is about to expire
← Back to Search
Eculizumab for Pediatric Neuromyelitis Optica Spectrum Disorder
Study Summary
This trial will test if eculizumab is safe and effective in treating NMOSD in children.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
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
Find a Location
Who is running the clinical trial?
Media Library
- I haven't used rituximab or similar drugs in the last 6 months.I've had at least 2 relapses in the past 2 years, including one in the last year.I am on a stable dose of medication to prevent my condition from returning.I am on a stable dose of medication to prevent my condition from returning.I am positive for anti-aquaporin-4 antibodies and have been diagnosed with NMOSD.I have been vaccinated against meningitis within the last 3 years or at the start of eculizumab treatment.I have been vaccinated against haemophilus influenzae type b and streptococcus pneumoniae according to my country's guidelines.I am not pregnant and will follow the birth control advice while on treatment and for 5 months after.I have not used intravenous immunoglobulin or had plasma exchange in the last 3 weeks.I am not pregnant and will follow the birth control advice while on treatment and for 5 months after.I have been treated with eculizumab or similar drugs before.I can walk with assistance.I agree to use double barrier contraception with my partner during and for 5 months after treatment.You have a serious infection that has not been fully treated yet.You have HIV or a condition that affects your immune system from birth.I haven't used MS immunotherapy in the last 3 months.I have not used mitoxantrone in the last 3 months.I am between 2 and 18 years old and weigh at least 10 kg.I do not have any untreated significant infections.I have been vaccinated against haemophilus influenzae type b and streptococcus pneumoniae according to my country's guidelines.I am between 2 and 18 years old and weigh at least 10 kg.I've had at least 2 relapses in the past 2 years, including one in the last year.I have been vaccinated against meningitis within the last 3 years or at the start of eculizumab treatment.
- Group 1: Eculizumab
- 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 study only enrolling individuals who are over 30 years old?
"In order to be eligible for this trial, patients must fall between the ages of 2 and 17. Out of the 923 total clinical trials being conducted, 264 are for patient under 18 years old and 659 are for patients over 65."
Are we still looking for participants in this experiment?
"The clinical trial is currently recruiting patients, with 12 needed in total. The study was first posted on 1/14/2020 and updated as recently as 4/6/2022. There are 20 sites where the research is being conducted."
Are there any restrictions on who is eligible to participate in this research project?
"This study is looking for 12 participants that have neuromyelitis optica and are between the ages of 2-17. To be eligible, candidates must: currently receive immunosuppressive therapies (IST) in order to prevent relapse, be on a stable dosing regimen for an adequate duration, have a negative pregnancy test at screening, follow contraception guidance to avoid pregnancy while taking the medication and for 5 months after the last dose of eculizumab, be vaccinated against haemophilus influenzae type b and streptococcus pneumoniae infections at least 2 weeks prior to dosing as per local and country"
Could you tell me how many individuals are participating in this clinical trial?
"In order to start this clinical trial, 12 willing and eligible participants are needed. The specified inclusion criteria must be met in order for an individual to take part in the study. There are different enrolling sites including Clinical Trial Site in Chapel Hill, North carolina and University of North Carolina School of Medicine at Chapel Hill in San Francisco, California."
Could you compare and contrast this clinical trial with others involving Eculizumab?
"The first clinical trial for eculizumab took place in 2016. To date, a total of 43 trials have been completed. Currently, there are 14 active clinical trials recruiting patients, with many of them located in Chapel Hill, North carolina."
Eculizumab is most commonly used for which medical condition?
"Eculizumab is the standard treatment for myasthenia gravis, generalized. This medication can also help patients with neuromyelitis optica, paroxysmal nocturnal haemoglobinuria (pnh), and thyroid stimulating immunoglobulins."
Where are patients able to participate in this trial?
"Currently, there are 20 available clinical trial sites. These include locations like Chapel Hill, University of North carolina School of Medicine at Chapel Hill in San Francisco, and University of California San Francisco (UCSF) in Boston."
Is this a new clinical trial?
"Research into eculizumab began in 2016 with a study sponsored by Alexion Pharmaceuticals. After the first successful trial, which had 270 participants, the Phase 3 drug approval process was completed and today there are 14 active studies involving eculizumab being conducted in 121 cities across 42 countries."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger