A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 16 years - 65 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosed with focal epilepsy.
    2. Patient or patient’s legal representative (i.e., parent or legal guardian) is willing and able to keep an accurate study/seizure diary, adhere to the protocol, and read, understand, and sign informed consent (assent), as applicable.
    3. Must have 8 countable, observable focal seizures during the 8-week baseline period prior to randomization, including at least 3 in each 4-week period with no 21-day seizure-free period.
    4. Must have had a brain MRI or contrast-enhanced head CT scan with an available report (images need not be available) that has been performed within the past 10 years and that is negative for confounding conditions such as tumor, infection, demyelinating disease, or other progressive neurological disease.
    5. Seizures uncontrolled after an adequate trial of at least 1 ASM within the last 2 years.
    6. Currently receiving treatment with 1-3 ASMs with doses stable for at least 4 weeks prior to screening.
    7. If participant has a vagal nerve stimulator (VNS), responsive neurostimulator (RNS) or deep brain stimulator (DBS), it must have been implanted and activated >1 year prior to screening, and stimulation parameters that have been stable for >3 months, and battery life of unit anticipated to extend for duration of trial.
    8. Females of childbearing potential who are not sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study, and then for 14 days following the last dose, must agree to use acceptable birth control method.

You may not be eligible for this study if the following are true:

    1. Pregnant or lactating.
    2. History of hypersensitivity to ivermectin.
    3. History of status epilepticus in the past 1 year from screening.
    4. History of pseudo- or nonepileptic seizures, or other nonepileptic events that could be confused with epileptic seizures, within the past 5 years.
    5. History of traumatic brain injury within 30 days prior to screening.
    6. Resective epilepsy surgery within 1 year; epilepsy-related radiosurgery within 2 years.
    7. History of progressive neurological disorder or other significant progressive disorder or unstable medical condition(s) that may confound study results.
    8. Psychiatric disorder where changes in pharmacotherapy are needed or anticipated during the study or which would interfere with the patient's ability to participate in the trial.
    9. Active suicidal plan/intent in the past 6 months, a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
    10. History of substance use disorder, including alcohol, within the past 2 years.
    11. Currently in another investigational drug study.
    12. Currently on felbamate for less than one year before visit 1 (aplastic anemia and hepatic failure usually occur within 6 months to one year).
    13. Currently on vigabatrin for less than 2 years before visit 1, as most visual field changes occur between 6 months and 2 years.
    14. Currently taking retigabine/ezogabine.
    15. History of intermittent use of rescue benzodiazepines (i.e. 1 to 2 doses over a 24-hour period is considered a 1-time rescue) more than once in the 4 weeks prior to the baseline visit or more than once per 4 weeks during the 8-week baseline period.
    16. Currently taking ivermectin, or has taken it within the last 4 weeks prior to visit 1.
    17. Has had a COVID-19 vaccination within the past 2 weeks prior to visit 1 (allowable to rescreen or to delay randomization).

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.