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AvailableNCT03778424

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

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

Status
Available
Phase
Study type
Expanded Access
Enrollment
Sponsor
Eisai Inc. · Industry
Sex
All
Age
4 Years
Healthy volunteers

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.

Conditions

Interventions

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

Timeline

First posted
2018-12-19
Last updated
2025-07-17

Locations

2 sites across 1 country: Poland

Source: ClinicalTrials.gov record NCT03778424. Inclusion in this directory is not an endorsement.

An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303 (NCT03778424) · Clinical Trials Directory