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:
  Focal Epilepsy
• Age: Between 18 years - 60 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Provide written consent form
  2. Have a BMI =18.5 and =35 kg/m2
  3. Have had the RNS® System implanted for more than 1 year and medically intractable focal onset epileptic seizures (history of persistent seizures refractory to two or more AEDs), with seizures from all foci represented in the implanted RNS electrodes
  4. Have a continuous period of at least 2 months with constant RNS detection and stimulation settings as well as stable AED as determined by medical history and PDMS
  5. Have 7 or more long episodes per month
  6. Have at least 50% of reviewed long episodes likely to be epileptic seizure as judged by an epileptologist
  7. Have a demonstrated history of compliance with RNS scanning and uploading procedure in the past year
  8. Remain sexually abstinent or use 2 methods of protocol approved contraception
  9. Are, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an ECG, and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests

  
  

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

• 1. Pregnant or breastfeeding
  2. Have an RNS System implanted in other regions than the epileptic foci such as the thalamus
  3. Have an RNS System with anticipated generator change in the coming 6 months
  4. Have less than 7 long episodes and/or more than 20% variability in week to week rate during the prospective Baseline Period
  5. Have taken disallowed medication less than 4 weeks prior
  6. Have orthostatic hypotension
  7. Have a QTc interval >450 ms (men) and >470 ms (women) (Fridericia’s correction)
  8. Have or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological (apart from epileptic diagnosis), or psychiatric disease or other major disorder, which in opinion of the investigator may influence efficacy or safety aspects in the study
  9. Have a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia
  10. Have had major surgery
  11. Have any concurrent disorder that may affect the pharmacological target or absorption, distribution, or elimination of the study drug
  12. Have had a clinically significant illness
  13. Have one or more clinical laboratory test values outside the reference range
  14. Tested positive for HIV
  15. Had surgery or trauma with significant blood loss or donated blood less than 3 months
  16. Current diagnosis or a history of substance or alcohol use disorder
  17. Significant risk of committing suicide based on history, mental status examination, investigator’s judgement, or C-SSRS answer of “yes” to question 4 or 5 (current or within the last 6 months) or patients with any suicidal behavior during the last 2 years
  18. Smokes or uses other nicotine containing products
  19. Trains/exercises intensively
  20. Have previously taken the investigational drug or has known hypersensitivity or intolerance to the study drug
  21. Have history of severe drug allergy or hypersensitivity
  22. Have regular cluster seizures with a frequency of less than one per month