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
- 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
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.