Envarsus for Toxic Encephalitis

Phase-Based Estimates
3
Effectiveness
3
Safety
Medical University of South Carolina, Charleston, SC
Toxic Encephalitis+2 More
Envarsus - Drug
Eligibility
18+
All Sexes
Eligible conditions
Toxic Encephalitis

Study Summary

This study is evaluating whether a new medication may help reduce neurologic side effects for liver transplant patients.

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Eligible Conditions

  • Toxic Encephalitis
  • Neurotoxicity Syndromes
  • Liver Transplant; Complications
  • Neurologic toxicity

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Envarsus will improve 1 primary outcome and 1 secondary outcome in patients with Toxic Encephalitis. Measurement will happen over the course of 6 months.

6 months
Change in mean Fahn-Tolosa-Marin (FTM) score
Change in neurotoxicity burden

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Arm 1: Control
Arm 2: Intervention

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Envarsus is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Arm 2: Intervention
Drug
Envarsus daily for 6 months.
Arm 1: Control
Drug
Tacrolimus immediate release twice daily for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Medical University of South Carolina - Charleston, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.
Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.

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 toxic encephalitis be cured?

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The incidence of treatment-related death from WEs is extremely rare in the cohort studied, and no definitive conclusions have been reached that treatment can be definitively curative.

Unverified Answer

What are common treatments for toxic encephalitis?

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Toxin exposure can cause a variety of neurologic disorders, so any common treatment should be based on the specific symptoms and the treatment goals are also determined by their severity. The current recommendation in the treatment of encephalitis is to administer intravenous immunoglobulin therapy early for prophylaxis and to administer the appropriate antibiotics when the underlying causative agent can be determined.

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How many people get toxic encephalitis a year in the United States?

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The data do not support the current public health recommendation to recommend screening patients with unexplained headache or flu-like symptoms with the aim of screening children for the presence of TE.

Unverified Answer

What causes toxic encephalitis?

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The presentation and course of TBE are influenced by the immune status of the infected person, the severity of disease, and the time elapsed until treatment; thus, immune status is a major factor influencing the outcome of the disease. Data from a recent study, our findings indicated that patients with TBE who were immunocompimporant had an improved outcome when compared to those who weren't immunocompimporant. The absence of any differences in some patient attributes suggests that immunosuppressing drugs, such as CIDP patients, might improve the immune response of a TBE patient.

Unverified Answer

What are the signs of toxic encephalitis?

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Most commonly, the first symptom is an altered level of consciousness and other symptoms often appear later. The most common sign is a lowered level of consciousness, and most of these patients will display abnormal neurological signs on physical examination in the form of diminished reflexes and muscle wasting. Other symptoms that may occur include headache, fever, confusion, confusion with encephalitis, vomiting, seizures and convulsion, and encephalitis-associated psychosis. Magnetic resonance imaging of the spine is the only imaging method to reveal the brain-spinal tract lesions of toxic encephalitis. In the meantime, a combination of electroencephalography (EEG) and neurologic examinations provide clinicians with helpful data.

Unverified Answer

What is toxic encephalitis?

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Toxins in the brain can affect many different brain processes, but mostly can trigger acute or chronic seizures. The most common way to test for potential Toxins in the brain is with an encephalopathy in the hospital or emergency department. The diagnostic work up usually includes imaging and EEG. Patients can also be tested for toxins in the blood, especially ammonia and methemoglobinemia. The treatment depends on the type, cause, and the severity of the encephalopathy.\n

Unverified Answer

How serious can toxic encephalitis be?

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Although it is believed that acute toxic encephalitis is more common, the presentation of acute toxic encephalitis is not benign. Serious sequelae and poor outcomes can occur with this disease.

Unverified Answer

Is envarsus safe for people?

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Despite recommendations, a [postdural puncture headache (PDPH)] occurs in more people with meningitis than enemas, despite the apparent risk. Further studies are required to determine whether enemas are safe for the management of people with meningitis.

Unverified Answer

Have there been any new discoveries for treating toxic encephalitis?

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The field of toxic encephalitis has not made any dramatic progress due to the limited knowledge about the disease mechanisms. It is unclear whether toxic encephalitis could be treated by one or multiple treatments. However, multiple therapies have failed to affect clinical manifestation of a few patients with toxic encephalitis. New treatment to treat toxic encephalitis in the future should focus on multiple treatments and multi sub type syndromes.

Unverified Answer

Is envarsus typically used in combination with any other treatments?

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The ENVAR system is well tolerated in this small patient population, but its use as a single modality is not shown in this study to reduce the number of patients experiencing pain or swelling.

Unverified Answer

What are the common side effects of envarsus?

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VEEs may affect the brain for one to six months after the administration of the vaccine. All patients in our study had headache, and one of the major contributors to poor HRQoL was headache. However, neurological symptoms such as headache and unsteady gait and unsteadiness should not be ignored in the diagnosis of VEEs.

Unverified Answer

What is the average age someone gets toxic encephalitis?

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It is the highest incidence of TI in the most critically ill and elderly of patients with severe illnesses. Therefore, there would be greater use of immunomodulatory therapies with advancing age, resulting in more risk of developing TI in the older critically ill.

Unverified Answer
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