CLINICAL TRIAL

BIIB093 for Edema

Recruiting · 18+ · All Sexes · Nuoro, Italy

Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

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About the trial for Edema

Eligible Conditions
Brain Edema · Stroke · Infarction · Edema · Stroke, Acute

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
BIIB093
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person has a sudden onset of symptoms due to a lack of blood flow to the brain in the MCA territory. show original
The study drug must be administered within 10 hours of symptom onset, or the last known normal time, in the investigator's judgement. show original
examinations are normal People who have a stroke may be included in the study as long as they don't show any neurological problems and they meet other requirements. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Month 6 and 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Month 6 and 12.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Part 1: Reduction in Midline Shift at 72 Hours
BASELINE UP TO 72 HOURS
Midline shift will be assessed by non-contrast computed tomography (NCCT) or MRI.
Part 1: Number of Participants Who Achieved mRS 0-4 at Day 90
BASELINE UP TO DAY 90
mRS is a standardized interview that measures the degree of disability or dependence in the daily activities of participants who have suffered causes of neurological disability. The score will be calculated as a 5-category ordinal scale. The 5-category mRS combines mRS categories 0 and 1 and mRS categories 5 and 6 (0/1, 2, 3, 4, 5/6). The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Part 1: Time to All-Cause Death
BASELINE UP TO DAY 90
Part 1: Percentage of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)
BASELINE UP TO DAY 90
mRS is a standardized interview that measures the degree of disability or dependence in the daily activities of people who have suffered causes of neurological disability. The score will be calculated as a 5-category ordinal scale. The 5-category mRS combines mRS categories 0 and 1 and mRS categories 5 and 6 (0/1, 2, 3, 4, 5/6). The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
BASELINE UP TO DAY 90
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.
Part 2: Number of Participants With SAEs
UP TO MONTH 12
A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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