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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03778424
Expanded Access Status : Available
First Posted : December 19, 2018
Last Update Posted : April 30, 2021
Information provided by (Responsible Party):
Eisai Inc.

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.

Condition or disease Intervention/treatment
Lennox Gastaut Syndrome Drug: Rufinamide

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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Treatment IND/Protocol
Official Title: An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03778424

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Contact: Eisai Medical Information 1-888-274-2378

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Generała Tadeusza Kościuszki 52 Available
Kielce, Poland
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Available
Poznań, Poland
Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc. Identifier: NCT03778424    
Other Study ID Numbers: E2080-E044-501
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Keywords provided by Eisai Inc.:
Central Nervous System
Brain Diseases
Additional relevant MeSH terms:
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Lennox Gastaut Syndrome
Pathologic Processes
Epileptic Syndromes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action