ClinicalTrials.gg
AvailableNCT03778424Updated Jul 8, 2026

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

An expanded access record providing Rufinamide in Lennox Gastaut Syndrome, sponsored by Eisai Inc.. Available at 2 sites in Poland. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Eisai Inc. · Expanded access

Study type
Expanded access
Access type
Individual patients · Treatment IND/protocol
Ages
4 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lennox Gastaut Syndrome

Keywords

  • Central Nervous System
  • E2080
  • Rufinamide
  • Epilepsy
  • Seizures
  • Brain Diseases
03

In context

Lennox Gastaut Syndrome

68 studies on the registry are indexed under Lennox Gastaut Syndrome; 14 are open to participants now.

Browse Lennox Gastaut Syndrome studies →

Lead sponsor

Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Participants were randomized to the other antiepileptic drug (AED) treatment group in study E2080-G000-303.
05

Access details

Study type
Expanded access
Access type
Individual patients · Treatment IND/protocol

Available treatment

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

06

Where to request access

2 of 2 sites recruiting
  • Generała Tadeusza Kościuszki 52
    Kielce, Poland
    Available
  • Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
    Poznan, Poland
    Available
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT03778424
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Dec 19, 2018
Last update
Jul 8, 2026

Study contacts

Eisai Medical Information
Contact
esi_medinfo@eisai.com
1-888-274-2378
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

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Discussion

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