Lennox Gastaut Syndrome Clinical Trial
Official title:
An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome
| NCT number | NCT03778424 |
| Other study ID # | E2080-E044-501 |
| Secondary ID | |
| Status | Available |
| Phase | |
| First received | |
| Last updated |
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.
| Status | Available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 4 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Generala Tadeusza Kosciuszki 52 | Kielce | |
| Poland | Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu | Poznan |
| Lead Sponsor | Collaborator |
|---|---|
| Eisai Inc. |
Poland,
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|---|---|---|---|
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