Study of EQU-001 for Uncontrolled Focal Onset Seizures

Inclusion Criteria:

1. Age 18- 65 years at time of informed consent
2. The subject or designee is willing and able to keep an accurate study diary, thesubject is able to adhere to the protocol, the subject or the subject's legalrepresentative is able read, understand, and sign informed consent, as applicable.
3. Diagnosed with focal epilepsy according to ILAE (2017) criteria. Diagnosis to includeclinical history and an EEG consistent with focal epilepsy. A normal interictal EEG isallowed when the clinical history is consistent with focal epilepsy.
4. Subject has no seizures that are not focal by the ILAE 2017 criteria
5. Subject must have 8 countable, observable focal seizures during the 8-week baselineperiod prior to randomization, including at least 3 in each 4-week period with no 21-day seizure-free period. These seizures must be observable (focal aware with motorcomponent, focal impaired awareness, focal to bilateral tonic-clonic) and as such maynot include focal aware seizures without a detectable motor component, aphasia, orother observable symptom.
6. 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 andthat is negative for confounding conditions such as tumor, infection, demyelinatingdisease, or other progressive neurological disease. Remote stroke that may representthe etiology for epilepsy is allowed. If no such CT or MRI report is available, apotential subject will be asked to undergo a head CT scan with intravenous contrast tomeet eligibility criteria prior to study enrollment.
7. Seizures uncontrolled after an adequate trial of at least 1 ASM within the last 2years.
8. Currently receiving treatment with 1-3 ASMs with doses stable for at least 4 weeksprior to screening. These medications must stay stable during the 8-week baselineperiod and during the 16-week treatment period. In the case that the plasma level of aconcomitant ASM changes, the subject and their physician may then modify the dose tomaintain the plasma level that was present prior to beginning the study drug. and mustdocument the change in the EDC system.
9. If participant has a vagal nerve stimulator (VNS), responsive neurostimulator (RNS) ordeep brain stimulator (DBS), it must have been implanted and activated >1 year priorto screening, and stimulation parameters that have been stable for >3 months, andbattery life of unit anticipated to extend for duration of trial.
10. Females of childbearing potential who are not sexually inactive (abstinent) for 30days prior to the first dose, throughout the study, and then for 30 days following thelast dose, must agree to use of one of the following acceptable birth control methodsfrom 30 days prior to the first dose through 30 days after the last dose of studydrug: i. Combined estrogen and progestogen containing hormonal contraception associated withinhibition of ovulation (oral, intravaginal, transdermal) together with a condom orother barrier method ii. Progestogen-only hormonal contraception associated withinhibition of ovulation (oral, injectable, implantable) together with a condom orother barrier method iii. Intrauterine device (IUD) together with a condom or otherbarrier method iv. Intrauterine hormone releasing system (IUS) together with a condomor other barrier method v. Bilateral tubal occlusion, hysterectomy, bilateraloophorectomy vi. Vasectomized partner (vasectomy >6 months ago) For this study, pre-menopausal is defined as not meeting the clinical criteria for postmenopausal, that is, no menstrual period for at least one year, in the absence of otheridentifiable cause(s) of not having a period, together with the absence of typical symptomsof menopause, such as hot flashes and mood instability. True abstinence is allowable whenin line with the preferred and usual lifestyle of the subject. Periodic abstinence (such ascalendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are notacceptable methods of contraception.

Exclusion Criteria:

1. Pregnant or lactating
2. History of hypersensitivity to ivermectin or to any of the excipients in the EQU-001gelcap
3. History of status epilepticus in the past 1 year from screening
4. History of pseudo- or nonepileptic seizures, or other nonepileptic events that couldbe 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 yearsor Ventriculoperitoneal shunt placement within 1 year
7. Presence of progressive neurological disorder or other progressive disorder orunstable medical condition(s) that may confound study results. History of long QTsyndrome, family history of sudden death of unknown cause.
8. Psychiatric disorder where changes in pharmacotherapy are needed or anticipated duringthe study or which would interfere with the subject's ability to participate in thetrial
9. Active suicidal plan/intent in the past 6 months, a history of suicide attempt in thelast 2 years, or more than 1 lifetime suicide attempt as evidenced by a positiveresponse to C-SSRS questions 4 or 5
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 andhepatic failure usually occur within 6 months to one year). If on felbamate,documentation of stable hemogram and liver enzyme tests must be present.
13. Currently on vigabatrin for less than 2 years before visit 1, as most visual fieldchanges occur between 6 months and 2 years Subjects on vigabatrin should haveavailable, appropriate documentation of visual fields.
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 tothe baseline visit or more than once per 4 weeks during the 8-week baseline period Ifa subject is taking benzodiazepines for an indication other than epilepsy (e.g.,anxiety, sleep), the dose should to be stable for at least 4 weeks prior to screeningand remain stable throughout screening and double blind periods of the study.
16. Currently taking ivermectin, or has taken it within the last 4 weeks prior to visit 1 17a. Use of the following medications within 4 weeks of the baseline visit and throughoutthe study that may interfere with study drug metabolism (please note ASMs with CYP3A4metabolism are not excluded from this study, as drug levels and safety are monitoredthroughout the study): i. CYP3A4 inducers: rifampin, lumacaftor, mitotane, enzalutamide, apalutamide, St. John'swort, glucocorticoids ii. Medications with PGP interactions: amiodarone, apalutamide, verapamil, lorlatinib,rifampin, St. John's wort 17b. Use of the following medications/foods is not strictly prohibited but is discouraged.Please make every attempt to refrain and to record each incidence of use of any of these (along with all medications and supplements): i. CYP3A4 inhibitors, including, but not limited to clarithromycin, ceritinib, idelalisib,lonafarnib, tucatinib, erythromycin, telithromycin, diltiazem, dronedarone, posaconazole,voriconazole, nefazodone, itraconazole, ketoconazole, anti-retroviral drugs (atazanavir,darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir), grapefruitand grapefruit juice, pomegranate fruit and pomegranate juice ii. Additional medications that may interact with CYP3A4, PGP, or Vitamin K: fluconazole,isavuconazole, cyclosporine, dronedarone, imatinib, warfarin, acenocoumarol
17. Has any of the following laboratory or exam abnormalities: i. Positive urine drugscreen (methamphetamines, amphetamines, cocaine, PCP, opioids, barbiturates) at screeningwithout a therapy related explanation ii. Positive hCG (female participants) (at screeningor visit 2/enrollment) iii. QTcF > 450 msec at visit 2/enrollment
18. Subject is not approved for study inclusion by the Epilepsy Consortium based on thediagnostic review form
19. Any condition that, in the opinion of the investigator, may impact a subject's safetyor ability to follow study procedures
20. History of 14 or more consecutive days in Angola, Equatorial Guinea, Gabon, Cameroon,the Central African Republic, the Republic of Congo, the DR of Congo, Nigeria, Chad, and/orSouth Sudan within the past 17 years and did not take diethylcarbamazine prophylaxis or hasnot been evaluated for/found to be negative for or treated for loa loa and subsequentlyevaluated as resolved since the most recent stay of at least 14 days.