Clinical Research Studies

Are you eligible to participate in this study?

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

• Conditions:
  Epilepsy,covid-19
• Age: Between 18 years - 75 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participant is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study.
  2. Age between 18 and 75 years old (inclusive) with a BMI =40 kg/m2 at Visit 1.
  3. Diagnosis (=2 years) of focal epilepsy.
  4. Prior neuroimaging within the last 10 years, with documentation available.
  5. Participant is on a stable dose of 1 to 3 allowable current anti-seizure medications (ASMs) for at least 1 month prior to screening
  6. Able to keep accurate seizure diaries.
  7. Willing to comply with the contraception requirements.
  8. Males must agree not to donate sperm from the time of the first administration of study drug until 3 months after the last dose of study drug. Females must agree not to donate ova from the time of the first administration of study drug until 6 months after the last dose of study drug.
  9. Individual with an implanted vagal nerve stimulator, deep brain stimulation, or responsive neurostimulator system will be allowed to participate in the study if the stimulator, stimulation, or neurostimulator system is present for >1 year prior to entry into the DBP, and the battery does not need to be replaced during the DBP. If stimulator is present for >1 year prior to entry into the DBP, the stimulation parameters must have been kept constant for >3 months prior to Visit 1 and for the duration of the study.
  10. Individual is able to participate for the full term of the study.

  
  

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

• 1. Individual has previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
  2. Individual has history of focal aware non-motor seizures only.
  3. Individual has a history of non-epileptic psychogenic seizures.
  4. Individual has history of a primary generalized seizure.
  5. Individual has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
  6. Individual is on a ketogenic diet at, or within 3 months prior to, Visit 1.
  7. Individual has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive CNS disease.
  8. Individual has history of drug or alcohol abuse within 1 year prior to Visit 1 that is judged by the investigator to be excessive or compulsive, or currently using drugs of abuse or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse, dependence, or habitual use.
  9. Individual has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
  10. Individual has status epilepticus within the last 12 months prior to Visit 1.
  11. Individual has history of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to enrollment.
  12. Individual has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, and/or obsessive-compulsive disorder, or other serious mental health disorders including uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.
  13. Individual had an active suicidal plan/intent in the past 6 months, history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
  14. Individual has history or presence of any significant medical or surgical condition or uncontrolled medical illness including, but not limited to, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, endocrine, hepatic (including those with mild, moderate, or severe hepatic impairment, defined as Child Pugh score >5), or urogenital systems, or other conditions that would place the subject at increased risk or prevent adherence to the protocol, as determined by the investigator.
  15. Individual has history of skin or retinal pigment epithelium abnormalities or maculopathy caused by ezogabine/retigabine.
  16. Individual has history of cancer within the past 2 years, with the exception of appropriately treated basal cell or squamous cell carcinoma.
  17. Female who is pregnant, breastfeeding, or planning to become pregnant from the first administration of study drug until 6 months after the last dose of study drug.
  18. Individual has any previous exposure to XEN1101.
  19. Individual has exposure to any other investigational drug or device within 5 half-lives or 30 days prior to Visit 1, whichever is longer.
  20. Use of vigabatrin in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin.
  21. Individual has had multiple drug allergies or a severe drug reaction to an ASM(s).
  22. Employees of Xenon Pharmaceuticals Inc., the CRO, or study site personnel directly affiliated with this study and their immediate family members. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.