Safety, Tolerability, and Exploratory Efficacy of Adjunctive EQU-001 for Seizures in Adults With Epilepsy

Exclusion Criteria

• •1. Pregnant or lactating female
• •2. History of hypersensitivity to ivermectin
• •3. Ivermectin use within 28 days of screening
• •4. History of progressive neurological disorder or other significant progressive disorder or unstable medical condition(s)
• •5. Change in AED regimen in the 28 days prior to screening
• •6. Taking \>4 concomitant AEDs at screening
• •7. History of status epilepticus in the 2 years prior to screening
• •8. A vagal nerve stimulator (VNS), responsive neurostimulator (RNS) or deep brain stimulator (DBS), implanted or activated \<1 year prior to screening, or with stimulation parameters stable for \<3 months or battery life of unit not anticipated to extend for the duration of the trial
• •9. History of traumatic brain injury within 28 days prior to screening
• •10. History of psychogenic non-epileptic seizures (PNES), active or within 2 years prior to study entry
• •11. Epilepsy-related surgery within 1 year prior to screening, epilepsy-related radiosurgery or laser surgery within 1 year prior to screening
• •12. Epilepsy dietary therapy initiated \<3 months prior to screening
• •13. Psychiatric disorder in which changes in pharmacotherapy are needed or anticipated during the study
• •14. Active suicidal plan/intent in the 6 months prior to screening and evidenced by a positive response to C-SSRS questions 4 or 5, a history of suicide attempt in the 2 years prior to screening, or more than 1 lifetime suicide attempt.
• •15. Administration of investigational product in another trial within 28 days prior to the first expected study drug administration, or five half-lives, whichever is longer.
• •16. Receiving felbamate for \<1 year prior to screening
• •17. Receiving vigabatrin for \<2 years prior to screening. Subjects on vigabatrin should have available, appropriate documentation of visual fields
• •18. Receiving ezogabine (ex-US) at screening
• •19. Use of the following medications and foods at screening or baseline that may interfere with study drug:
• •1. CYP3A4 inducers: rifampin, lumacaftor, mitotane, enzalutamide, apalutamide, St. John's wort, glucocorticoids
• •2. CYP3A4 inhibitors including and not limited to: clarithromycin, ceritinib, idelalisib, lonafarnib, tucatinib, erythromycin, telithromycin, diltiazem, ketoconazole, posaconazole, voriconazole, telithromycin, nefazodone, mifepristone, itraconazole, ketoconazole, anti-retroviral drugs (atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir), grapefruit and grapefruit juice, pomegranate and pomegranate juice
• •3. Additional medications that may interact with CYP3A4, PGP, or Vitamin K: fluconazole, isavuconazole, cyclosporine, amiodarone, dronaderone, verapamil, imatinib, warfarin, acenocoumarol
• •20. Has any of the following laboratory abnormalities at screening:
• •1. Positive COVID test
• •2. Positive urine drug screen (except as clinically indicated)
• •3. Total bilirubin or higher ≥1.5× the site laboratory upper limit of normal (ULN)
• •4. ALT or ALT ≥2× the site laboratory ULN
• •5. HbA1c \>7.0%
• •6. Positive hCG (female participants) (screening or baseline)
• •21. Subject is not approved for study inclusion by the Epilepsy Consortium based on the diagnostic review form
• •22. Any condition that, in the opinion of the investigator, may impact a subject's safety or ability to follow study procedures.