An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
1 other identifier
expanded_access
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedJuly 17, 2025
July 1, 2025
November 27, 2018
July 14, 2025
Conditions
Keywords
Interventions
Rufinamide up to 45 milligram per kilogram per day (mg/kg/day).
Eligibility Criteria
You may qualify if:
- Participants who were on rufinamide treatment and have completed Study E2080-G000-303 in Poland.
You may not qualify if:
- Participants were randomized to the other antiepileptic drug (AED) treatment group in study E2080-G000-303.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (2)
Generała Tadeusza Kościuszki 52
Kielce, Poland
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2018
First Posted
December 19, 2018
Last Updated
July 17, 2025
Record last verified: 2025-07