Frequently Asked Questions Regarding The ExTINGUISH Clinical Trial
Posted on December 10, 2021
ICYMI, please find a link to the Breaking News Announcement, regarding the ExTINGUISH Clinical Trial which we made on December 1, 2021. Today, we are pleased to provide you with some Frequently Asked Questions regarding the ExTINGUISH Trial:
Frequently Asked Questions
We are doing this research to find out whether inebilizumab, is well tolerated and safe when it is given to patients with NMDAR Encephalitis as two separate infusions given 14 days apart. As part of this study, we will ask recovering participants to complete a number of questionnaires.
1. Where is this study taking place?
The study is coordinated by NeuroNEXT, the Network for Excellence in Neuroscience Clinical Trials, with support and funding from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH), and Horizon Pharmaceuticals. It is taking place at 20 centers across the U.S and 2 centers in Europe (Barcelona, Spain and Rotterdam, Netherlands).
2. What are some of the basic things necessary for me to be eligible in the study?
- You must be at least 18 years old and have sufficient English skills for the study questionnaires.
- You must have a diagnosis of NMDAR Encephalitis that has not been treated with other immunotherapies.
3. What is Inebilizumab and how does it work?
Inebilizumab is a promising therapeutic monoclonal antibody for the treatment of NMDAR encephalitis. This humanized monoclonal antibody against the B-cell surface antigen CD19 was recently shown to be safe and efficacious in the treatment of neuromyelitis optica spectrum disorder-another antibody-mediated disorder of the central nervous system. Compared to other off label B-cell depleting therapies, such as rituximab, inebilizumab not only depletes CD20+ B-cells, but also CD20- plasmablasts and plasma cells, resulting in robust and sustained suppression of B-cell expression.
4. What are the side effects of Inebilizumab?
Inebilizumab can cause infusion reactions that can be serious. If you develop an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion and treat your symptoms. Low blood cell counts, and Infections can happen during treatment, and you will need to be checked for the presence of unknown infection exposure prior to infusion, including for hepatitis and tuberculosis. The most common side effects include urinary tract infection and joint pain.
Inebilizumab is given through a needle placed in a vein (IV or intravenous infusion) in your arm.
Before treatment with inebilizumab, your healthcare provider will give you a corticosteroid medicine, an antihistamine, and a fever prevention medicine to help infusion reactions become less frequent and less severe. Each infusion will last about 1 hour and 30 minutes.
5. How does this benefit me?
You may or may not benefit from taking part in this research study. Others with NMDAR Encephalitis may benefit in the future from what we learn in this study.
6. When does the study begin and end?
NN111 EXTINGUISH is actively enrolling participants. To learn more information, please email ExTINGUISH@hsc.utah.edu. The study will end after the last participant enrolled has completed the 24-week follow-up visit.
7. How long will I be in the study?
You will first attend a screening visit to determine whether or not you are eligible. If you are eligible, you will
8. Will I receive compensation for participating in this study?
You will not receive compensation for participating in this study.
9. What is NMDAR Encephalitis?
N-methyl-D-aspartate receptor (NMDAR) encephalitis is one of the most common causes of autoimmune encephalitis, with prevalence exceeding herpes encephalitis in industrialized nations. Typically, the disease affects patients aged 10-50 causing prominent psychiatric symptoms, altered consciousness, seizures, movement disorders and life-threatening dysautonomia. Intensive care, including cardiorespiratory support is required in 75% of cases. The diagnosis is confirmed by detection of IgG autoantibodies against central nervous system NMDAR in the cerebrospinal fluid.
10. What is NeuroNEXT?
NeuroNEXT is the Network for Excellence in Neuroscience Clinical Trials. It is a National Institute of Neurological Disorders and Stroke (NINDS) initiative to conduct exploratory trials in neurological conditions that receives proposals from academics, foundations and industry. NeuroNEXT consists of a Clinical Coordinating Center based out of Massachusetts General Hospital in Boston, Massachusetts, a Data Coordinating Center based out of the University of Iowa in Iowa City, Iowa and over 25 Clinical Sites throughout the United States.
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