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Vigabatrin for Post-anoxic Seizures (VIGAB-STAT Trial)
VIGAB-STAT Trial Summary
This trial is testing a new treatment for seizures that occur after a person has been without oxygen for a period of time.
VIGAB-STAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVIGAB-STAT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VIGAB-STAT Trial Design
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Who is running the clinical trial?
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- You have had seizures all over your body before.You had a seizure before starting the brain wave monitoring.You had a sudden stop in your heart that wasn't caused by an injury, and your doctor has decided that you need treatment for continuous abnormal brain activity.You need anesthesia for any reason.You need to have a good artery that can be used to take blood samples often.You have a tube inserted into your stomach within 48 hours after having a certain type of prolonged seizure.
- Group 1: Open label
- 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
Am I eligible to join this experimentation?
"This medical research is searching for 22 individuals suffering from a coma, aged between 18 and 80. Criteria to be eligible are non-traumatic cardiac arrest (regardless of etiology or location), the presence of electrographic status epilepticus as defined by the American Clinical Neurophysiology Society (generalized spike/sharp-wave discharges ≥ 3Hz or any evolving pattern reaching > 4Hz, lasting ≥ 10 minutes, or comprising > 50% of any hour of recording) and reliable arterial access for frequent blood sampling."
Has the Food and Drug Administration certified Vigabatrin as a sole therapeutic agent?
"We have given Vigabatrin Only Product a security rating of 2 based on the data currently available from Phase 2 trials, which confirms its safety but does not demonstrate efficacy."
Could you please expound on the past experiments conducted using Vigabatrin Only Product?
"Presently, 7 trials relating to Vigabatrin Only Product are in progress. Two of these investigations have progressed to Phase 3. 44 distinct sites across Birmingham, Alabama are conducting the research into this medicine's efficacy and safety."
Are persons of age 18 and above welcome to join this trial?
"According to the criteria listed on this trial, patients aged 18 - 80 are eligible for enrollment. For those below and above these respective age groups, there are 11 studies tailored to minors and 14 specifically designed for elderly individuals."
To what extent has the clinical trial been tested on participants?
"Affirmative. According to records on clinicaltrials.gov, this research endeavour is actively recruiting participants since it was first declared on September 22nd 2021 and last updated on the 19th of September 2022. The trial requires a total of 22 individuals at one medical centre."
Is this trial currently recruiting participants?
"Affirmative. Data stored on clinicaltrials.gov affirms that this medical research, which was initially posted September 22nd 2021, is actively seeking applicants. Approximately 22 volunteers must be sourced from one location."
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