A phase-3 study of a once-daily, oral treatment for those living with focal seizures

Age: 18 years - 66+

Gender: N/A

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: May 03, 2023

End Date: May 22, 2028

Contact Information:
Onome Eka, MBBS, MPH
212-241-8861
Summary:

 

  • Randomized, Double-blind [study drug at 25mg, 15 mg or a placebo]
  • Duration: 7 months
  • Study visits: 9 study visits (7 Onsite and 2 telephone visits)
  • Study activities:
    • Blood, Urine and Stool sample collection
    • Complete surveys/questionnaires
    • Eye Exam, ECG
  • Compensation Provided
Eligibility:

 

Inclusion criteria:

  • Participant is 18 years or older.
  • Participant is diagnosed with focal epilepsy for two years or more.
  • Participant must have had a documented seizure frequency of ≥4 countable focal seizures per 28 days on average.
  • Participant has tried 2 anti-seizure medications without lasting seizure freedom.
  • Participant has been taking stable doses of 1 to 3 medications for seizures for at least 1 month.

Exclusion criteria:

  • Participant has previously documented EEG which shows any pattern not consistent with focal etiology of seizures.
  • Participant has a history of focal aware non-motor seizures only.
  • Participant has a history of non-epileptic psychogenic seizures.
  • Participant has a history of a primary generalized seizure.