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NCT03778424 Clinical Trial

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

Lennox Gastaut Syndrome Clinical Trial

Official title:
An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT03778424
Other study ID # E2080-E044-501
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date May 2024
Source Eisai Inc.
Contact Eisai Medical Information
Phone 1-888-274-2378
Email esi_medinfo@eisai.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Poland Generala Tadeusza Kosciuszki 52 Kielce
Poland Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Poznan

Sponsors (1)
Lead Sponsor Collaborator
Eisai Inc.

Country where clinical trial is conducted

Poland, 

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