A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED PARALLEL GROUP MULTICENTER TRIAL OF CVL-865 AS ADJUNCTIVE THERAPY IN ADULTS WITH DRUG-RESISTANT FOCAL ONSET SEIZURES (REALIZE TRIAL)

Are you eligible to participate in this study?

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

  • Conditions:
    Epilepsy
    Focal Epilepsy
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. A diagnosis of epilepsy with focal onset, focal aware, focal impaired awareness, and focal to bilateral tonic-clonic seizures for at least 2 years prior to consent
    2. History of an average of 4 or more spontaneous and observable focal onset, focal aware, focal impaired awareness, and focal to bilateral tonic-clonic seizures during the 8-week Baseline Period with no 21-day seizure-free period.
    3. Tried and failed at least 2 appropriate anti-epileptic drugs (AEDs) in the past
    4. Currently taking 1 to 3 permitted AEDs at a stable dose for 4 weeks prior to the Screening Visit
    5. An MRI or CT scan of the head within 10 years prior to Screening Visit to demonstrate no progressive structural abnormality
    6. BMI of 17.5 to 40.0 kg/m2 and a total body weight >50 kg (110 lbs)
    7. Must agree to use highly effective method of contraception
    8. Able to understand the nature of the study and comply with the requirements of the study

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

    1. Genetic idiopathic generalized epilepsies or combined generalized and focal epilepsies, including a history of Lennox-Gastaut Syndrome.
    2. Have only focal aware seizures without a motor component.
    3. History of seizures over the past 12 months that occur at such a high frequency they cannot be counted
    4. History of psychogenic non-epileptic seizures within the year prior
    5. History of status epilepticus within 5 years prior
    6. History of neurosurgery for seizures less than 1 year prior
    7. Current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological (excluding focal onset epilepsy) disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial.
    8. Severe psychiatric illness
    9. An active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive
    10. History of substance or alcohol-use disorder
    11. Recent suicidal thoughts or behavior (within the last 6 months).
    12. Positive test for human immunodeficiency virus, hepatitis B or C infection.
    13. Positive drug screen for illicit drugs
    14. Subjects with significant abnormalities in laboratory test results, vital sign results, or ECG findings.
    15. Taking more than 3 background AEDs to treat epilepsy.
    16. Taking benzodiazepine (BZD) medication chronically.
    17. Taking any medications prohibited in this study.
    18. Female subjects who are breastfeeding and/or who have a positive pregnancy test result prior to receiving study drug
    19. Any condition possibly affecting drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding).
    20. Difficulty swallowing.
    21. Participated in any clinical trial within 60 days or 2 clinical trials within a year
    22. Any subject who, in the opinion of the sponsor, investigator, or medical monitor, should not participate in the trial.



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