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NCT03778424

An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303

Sponsor: Eisai Inc.

View on ClinicalTrials.gov

Summary

This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP.

Official title: An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome

Key Details

Gender

All

Age Range

4 Years - Any

Study Type

EXPANDED_ACCESS

Enrollment

Not specified

Start Date

Not specified

Completion Date

Not specified

Last Updated

2026-07-08

Healthy Volunteers

Not specified

Interventions

DRUG

Rufinamide

Rufinamide up to 45 milligram per kilogram per day (mg/kg/day).

Locations (2)

Generała Tadeusza Kościuszki 52

Kielce, Poland

Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, Poland