Clinical Trial: A Long Term Extension Study of E2080 in Lennox-Gastaut Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Long Term Extension Study of E2080 in Lennox-Gastaut Patients

Brief Summary: To investigate the safety of long term administration of E2080 in the patients with Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.

Detailed Summary:
Sponsor: Eisai Co., Ltd.

Current Primary Outcome: Number of patients with adverse events as a measure of Safety and Tolerability. [ Time Frame: 2 Years ]

Original Primary Outcome: Number of patients with adverse events as a measure of Safety and Tolerability [ Time Frame: 2 Years ]

Current Secondary Outcome: Change in the number of seizures of Epilepsy (tonic seizure or cataplexy) [ Time Frame: 12 weeks to 52 weeks ]

Original Secondary Outcome: Same as current

Information By: Eisai Inc.

Dates:
Date Received: June 14, 2010
Date Started: November 2010
Date Completion:
Last Updated: February 20, 2014
Last Verified: February 2014