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

NCT ID: NCT03778424

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Lennox Gastaut Syndrome

Interventions

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Rufinamide

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Generała Tadeusza Kościuszki 52

Kielce, , Poland

Site Status AVAILABLE

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

Poznan, , Poland

Site Status AVAILABLE

Countries

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Poland

Central Contacts

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Eisai Medical Information

Role: CONTACT

1-888-274-2378

Other Identifiers

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E2080-E044-501

Identifier Type: -

Identifier Source: org_study_id

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