Back to resultsAn Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
Primary Purpose
Lennox Gastaut Syndrome
Status
Available
Phase
Locations
Poland
Study Type
Expanded Access
Intervention
Rufinamide
Sponsored by
About this trial
This is an expanded access trial for Lennox Gastaut Syndrome focused on measuring Central Nervous System, E2080, Rufinamide, Epilepsy, Seizures, Brain Diseases
Eligibility Criteria
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.
Sites / Locations
- Generała Tadeusza Kościuszki 52
- Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03778424
Brief Title
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
Official Title
An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lennox Gastaut Syndrome
Keywords
Central Nervous System, E2080, Rufinamide, Epilepsy, Seizures, Brain Diseases
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rufinamide
Intervention Description
Rufinamide up to 45 milligram per kilogram per day (mg/kg/day).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eisai Medical Information
Phone
1-888-274-2378
Email
esi_medinfo@eisai.com
Facility Information:
Facility Name
Generała Tadeusza Kościuszki 52
City
Kielce
Country
Poland
Individual Site Status
Available
Facility Name
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznań
Country
Poland
Individual Site Status
Available
12. IPD Sharing Statement
Learn more about this trial
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
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