A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506688-32-00

Acronym

YKP3089C033

Enrollment

Registered

2024-05-10

Start date

2019-10-09

Completion date

Unknown

Last updated

2025-12-10

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

Conditions

Primary Generalized Tonic-Clonic Seizures

Brief summary

The primary endpoints are safety measures: the incidences of adverse events (AEs) and serious adverse events (SAEs); summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination, and electrocardiogram (ECG) findings.

Interventions

DRUGPlacebo matching with 12.5mg

DRUG25mg

DRUG50mg

DRUG100mg cenobamate tablets and 10mg/kg cenobamate oral suspension unit strength

DRUGCenobamate 12.5mg

DRUGCenobamate 50mg

DRUGCenobamate 25mg

DRUGCenobamate 100mg

DRUGCenobamate 10mg/mL

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoints are safety measures: the incidences of adverse events (AEs) and serious adverse events (SAEs); summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination, and electrocardiogram (ECG) findings.	—

Countries

Germany, Hungary, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026