An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526361-15-00

Enrollment

Registered

2026-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Onset Seizures

Brief summary

1. Incidence of treatment-emergent adverse events (TEAEs), 2. Change from baseline (CFB) in clinical laboratory test results at scheduled visits, 3. CFB in vital signs measurements at scheduled visits, 4. CFB in 12-lead electrocardiogram (ECG) findings at scheduled visits, 5. Columbia-Suicide Severity Rating Scale (C-SSRS) scores at scheduled visits

Interventions

DRUGHuperzine A

DRUGPlacebo capsules matching SPN-817 capsules for all strengths to be used during the Dose Titration/Bridging Period.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence of treatment-emergent adverse events (TEAEs), 2. Change from baseline (CFB) in clinical laboratory test results at scheduled visits, 3. CFB in vital signs measurements at scheduled visits, 4. CFB in 12-lead electrocardiogram (ECG) findings at scheduled visits, 5. Columbia-Suicide Severity Rating Scale (C-SSRS) scores at scheduled visits	—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 21, 2026