Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03474770 | BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures | PHASE1 | ACTIVE NOT_RECRUITING | 16 | — | — | Apr 10, 2018 | Dec 30, 2026 | Aug 30, 2022 | 2 | Australia |
Reduction in average daily seizure count between baseline (pre-treatment) and evaluation (on treatment) video EEG monitoring periods.
| Arm | Type | Description |
|---|---|---|
| BIS-001ER | EXPERIMENTAL | Dose administration for each participant will begin at 0.25mg b.i.d. escalating sequentially every 4 days to a maximum tolerated dose or target dose of 1.75mg b.i.d. Upon reaching the target dose or maximum tolerated dose, participants will maintain that dose for the balance of the 1 month out-patient titration period, after which they will begin a 96-hour in-patient video EEG monitoring treatment period. |
| Name | Type | Description |
|---|---|---|
| BIS-001ER | DRUG | BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A. |
Inclusion Criteria: * Speak English with sufficient proficiency to read and comprehend the Informed Consent document, and to communicate with study staff. * Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study. *...