The purpose of this study is to examine safety signals and demonstrate seizure reduction in adults with FIAS treated with BIS-001ER as an add-on therapy in an in-patient and out-patient study design.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Effect of BIS-001ER on Seizure Count
Reduction in average daily seizure count between baseline (pre-treatment) and evaluation (on treatment) video EEG monitoring periods.
Time frame: 6 Weeks
Effect of BIS-001ER on Percent Reduction in Daily Seizure Count
Percent reduction in average daily seizure count from the baseline VEM period compared to the evaluation video EEG monitoring period (on treatment).
Time frame: 6 Weeks
Effect of BIS-001ER on Seizure Count vs Titration Period (Diary)
Percent reduction in average number of seizures from the baseline period. (screening/retrospective diary) compared to the last week of the titration treatment period.
Time frame: 6 Weeks
Percent of Treatment Responders
Percent of participants considered treatment responders defined as those with a ≥25%, ≥50%, ≥75% reduction in seizures from the baseline VEM period compared to the VEM treatment evaluation period.
Time frame: 6 Weeks
Effect of BIS-001ER on Seizure Count During Extension Phase
Percent reduction of average number of seizures vs. baseline/retrospective diary at 1, 3, 6, 12 months during the extension period.
Time frame: 12 Months
Complete Seizure Protection
Proportion of subjects with 100% seizure reduction.
Time frame: 6 Weeks
Need for Rescue Medication
Proportion of subjects requiring rescue medication at different dosages.
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Time frame: 6 Weeks