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EQU-001 for Focal Onset Seizures
Study Summary
This trialis testing an add-on anti-seizure drug to treat uncontrolled focal onset seizures in adults 18-65. It will assess safety and efficacy over 16 weeks.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have had thoughts of hurting yourself in the past 6 months, or have tried to hurt yourself in the last 2 years, or have tried more than once in your life.You have had problems with using drugs or alcohol in the past 2 years.You have had a bad reaction to ivermectin or any of the ingredients in the EQU-001 gelcap.You have had a severe seizure within the past year before the screening.You are between 18 and 65 years old when you agree to take part in the study.You cannot take certain medications that might affect how the study drug works, starting 4 weeks before the study begins and throughout the study.You have specific abnormal results from blood tests or other medical exams.You have been taking felbamate for less than a year before the first study visit.You have had seizures that are not caused by epilepsy or events that look like seizures in the past 5 years.You are currently using the medication retigabine/ezogabine.You have traveled to specific places and taken preventive medicine.You need to have at least 8 noticeable seizures in the 8 weeks before starting the study.You need to have had a brain scan within the past 10 years that shows no major problems.You have had seizures that could not be controlled with medication in the last 2 years.You had surgery for epilepsy within the last year, had radiosurgery for epilepsy within the last two years, or had a shunt placed within the last year.You have a mental health condition that requires changes in medication during the study.You have been taking vigabatrin for less than 2 years before the first visit.You have used rescue benzodiazepines more than once in the 4 weeks before the study starts.You are currently using or have used ivermectin in the past 4 weeks before the first visit.You have been diagnosed with focal epilepsy based on specific criteria and tests.
- Group 1: EQU-001 60 mg
- Group 2: EQU-001 20 mg
- Group 3: EQU-001 0 mg
- 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
Does the eligibility criteria for this research permit individuals under 30 years of age?
"This scientific investigation is open to participants aged 18 and over, who are under the age of 65."
Has the Food and Drug Administration (FDA) sanctioned EQU-001 20 mg?
"Although there is limited evidence of EQU-001 20 mg's efficacy, the existing data on its safety was sufficient to confer a rating of 2."
Are there still vacancies available to participate in this experiment?
"The trial is actively searching for participants and the data available on clinicaltrials.gov reveals that it was initially launched January 1st, 2023 with its last update being made twenty-five days later."
How many participants are enrolled in this scientific experiment?
"To properly run this clinical trial, 300 patients that meet the outlined inclusion criteria must be enrolled. Thus far, two sites have been identified: Mid-Atlantic Epilepsy and Sleep Center in Bethesda, Maryland and Northeast Regional Epilepsy Group in Hackensack, New jersey."
In what number of healthcare facilities is this research experiment being conducted?
"Patients are being accepted at Bethesda's Mid-Atlantic Epilepsy and Sleep Center, Hackensack's Northeast Regional Epilepsy Group, Saint Barnabas' Institute of Neurology and Neurosurgery in Livingston Oklahoma as well as 7 other sites."
Who meets the eligibility criteria to join this clinical investigation?
"This clinical trial is presently accepting 300 volunteers with partial seizures aged between 18 and 65. Notably, applicants must meet the following requisites: be compliant to ILAE 2017 focal seizure guidelines; have suffered 8 countable episodes of focal aware or impaired awareness seizures over an eight-week time frame, 3 in each four week period; possess a MRI/CT negative for any confounding conditions within the last decade; receive stable doses of 1-3 ASMs prior to screening during baseline and treatment periods (which can vary); if equipped with VNS, RNS or DBS technology then it must've been installed at least one year before enrollment date"
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