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

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ClinicalTrials.gov Identifier: NCT03778424
Expanded Access Status : Available
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
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).

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

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 ClinicalTrials.gov identifier (NCT number): NCT03778424


Contacts
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Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

Locations
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Poland
Generała Tadeusza Kościuszki 52
Kielce, Poland
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznań, Poland
Sponsors and Collaborators
Eisai Inc.

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03778424     History of Changes
Other Study ID Numbers: E2080-E044-501
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: October 2018
Keywords provided by Eisai Inc.:
Central Nervous System
E2080
Rufinamide
Epilepsy
Seizures
Brain Diseases
Additional relevant MeSH terms:
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Lennox Gastaut Syndrome
Syndrome
Disease
Pathologic Processes
Epileptic Syndromes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Rufinamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action