Trial intelligence / Profile preview

BIS-001-ER for Adult Focal Impaired Awareness Seizures

NCT03474770Phase 2

Key facts

Status: Active, not recruiting
Start: Apr 2018
Primary completion: Dec 2026
Countries: 1
Sponsor: Supernus Pharmaceuticals, Inc.
Modality: Nucleic Acid-Directed Small Molecules, Covalent Small Molecules, Classical Binding Small Molecules

Drugs: Huperzine A
Conditions: focal impaired awareness seizure (FIAS)

Overview

Phase 2, open-label, single-arm trial of Huperzine A in focal impaired awareness seizure (FIAS), sponsored by Supernus Pharmaceuticals, Inc. Primary endpoint: Effect of BIS-001ER on Seizure Count at 6 weeks. Started Apr 2018; status: active, not recruiting.

Design

1 arm

Study design: Non-randomizedOpen-label

BIS-001ER
BIS-001ER titration and maintenance

Who it enrols

Adults with focal impaired awareness seizures on stable doses of 1-4 AEDs, with at least 5 seizures/week.

Endpoints

Primary

Effect of BIS-001ER on Seizure Count6 weeks

Secondary

Effect of BIS-001ER on Percent Reduction in Daily Seizure Count6 weeks
Percent of Treatment Responders6 weeks
Effect of BIS-001ER on Seizure Count During Extension Phase12 months
Complete Seizure Protection6 weeks
Need for Rescue Medication6 weeks

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