BIIB093 for Edema
Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
See full descriptionAbout the trial for Edema
Treatment Groups
This trial involves 2 different treatments. BIIB093 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether BIIB093 will improve 1 primary outcome, 4 secondary outcomes, and 7 other outcomes in patients with Edema. Measurement will happen over the course of Baseline up to 72 hours.
Patient Q & A Section
Can edema be cured?
Edema can not be cured. With appropriate therapy, this symptom can be dramatically improved. We hope that our study can encourage doctors to take care of their patients, for edema can be easily managed by a healthy life.
What is edema?
Edema is water retention usually resulting from an underlying medical condition. It can manifest itself in various ways such as: fluid accumulation in the ankles, ankles and wrists, abnormal sensation or swelling of the feet, hands or lower legs, heaviness of the limbs, heaviness in the abdomen, shortness of breath following exercise or prolonged periods of standing.
What are common treatments for edema?
Edema seems quite common in patients with severe AN, despite low body mass index, and despite the use of oral contraceptive pills. Given that intravenous fluid therapy alone is as effective as oral caloric intake for treatment of dehydration or cachexia, some patients may present with edema and should be investigated for its cause.
What causes edema?
Edema is caused by a variety of mechanisms. The causes can be listed as: excess fluid (dehydration), an excess of salts (osmotic theory), increased compliance of arteries (e.g. arterial hypertension), and increased protein clearance (e.g. excess protein in plasma).
What are the signs of edema?
Edema may be present in a child with PVS, especially when the child has decreased cerebral perfusion and fluid overload. Edema in the brain is typically seen in children with acute hypoxic stress. In patients in the PVS for a long time, edema is likely due to hypoperfusion, tissue necrosis, and possibly irreversible brain damage.
How many people get edema a year in the United States?
A very large proportion of patients do not get edema or the edema they do get has clinically important consequences. This underscores the need for effective education campaigns on which patients should be evaluated and for further prospective studies.
How does biib093 work?
There were some changes in the pharmacokinetics of 2 g/day of biib093 over a 28-days interval. The safety and pharmacokinetics of biib093, in this cohort of patients, were well tolerated with no significant change in QTc. However, further investigations into the pharmacokinetics of biib093 are important.
What are the latest developments in biib093 for therapeutic use?
Biib093 is a novel oral drug, under development by Gilead Sciences as its main mechanism of action is thought to be through inhibition of the c-Met tyrosine kinase receptor. Gilead’s clinical-trial portfolio for the development of biib093/mAb is largely limited to a proof of concept study demonstrating the potential for clinical benefit in subjects with advanced non-small-cell lung carcinoma (nsCLC) and a Phase I study in patients who had received prior treatment with c-Met mAb.
Does edema run in families?
Edema was more prevalent in patients with CAD, suggesting that edema may run in families. Further studies are needed to investigate the genetic mechanisms involved in edema and other CAD-related characteristics.
Have there been any new discoveries for treating edema?
Although the results to date have been limited in the number of trial patients, there are many promising new findings and some are getting closer to being in clinical trials. However, there are other factors beyond the number and quality of clinical trials that determine whether or not a new drug is going to be available for any medical use.
Who should consider clinical trials for edema?
Despite the increasing emphasis on cost-effectiveness analysis in the medical arena, there are still people who do not consider clinical trials as an important avenue for clinical care. Furthermore, patients may be insufficiently informed about clinical trials or their potential benefits. Therefore, there is a need to educate health care providers about and educate patients on clinical trials, especially those that can substantially reduce cost and pain. As clinical trial numbers grow, the need for accurate information will be greater, particularly for patients considering clinical trials. A web forum (www.mediabox.com) was developed to address the need for and the demand for a patient-friendly source of information about clinical trials.
What is the primary cause of edema?
There are five most common causes of edema. This article reviews the possible causes of peritoneal and pleural edema with the most important clinical presentations.