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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
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03778424
Enrollment
Unknown
Registered
2018-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-17

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

Conditions

Lennox Gastaut Syndrome

Keywords

Central Nervous System, E2080, Rufinamide, Epilepsy, Seizures, Brain Diseases

Brief 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.

Interventions

DRUGRufinamide

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

Sponsors

Eisai Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum

Inclusion criteria

* Participants who were on rufinamide treatment and have completed Study E2080-G000-303 in Poland.

Exclusion criteria

* Participants were randomized to the other antiepileptic drug (AED) treatment group in study E2080-G000-303.

Countries

Poland

Contacts

Primary ContactEisai Medical Information
esi_medinfo@eisai.com1-888-274-2378

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026