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BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures

Study acronym: FIAS
StatusActive, Not Recruiting
PhasePhase 1/2
Started2018-04-10
View on ClinicalTrials.gov ↗

Amendment history

2022-08-29
Study Status v2
Re-verified, no change to tracked fields
2021-04-13
Recruiting→Active, Not Recruiting Study Status, Sponsor/Collaborators, Contacts/Locations v1
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2018-11-30→2026-12-30
Completion date2018-11-30→2026-12-30
Start dateestimated 2018-04-02→confirmed 2018-04-10
Study sitesdetails revised at 2 of 2 sites
Collaborators-46 characters
Biscayne Neurotherapeutics Australia Pty, Ltd.
2018-03-21
Original filing
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.
Trial Details
NCT Number NCT03474770
Lead Sponsor Supernus Pharmaceuticals, Inc.
Conditions Focal Impaired Awareness Seizures
Enrollment 16 participants
Start Date 2018-04-10
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2022-08-30