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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01151540
First received: June 14, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Lennox-Gastaut Syndrome
Drug: E2080
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long Term Extension Study of E2080 in Lennox-Gastaut Patients

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Number of patients with adverse events as a measure of Safety and Tolerability. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in the number of seizures of Epilepsy (tonic seizure or cataplexy) [ Time Frame: 12 weeks to 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: November 2010
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E2080
The target dosage is approximately 45 mg/kg/day, taken orally twice a day.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria;

  1. Patients who have completed the evaluation of week 12 of the E2080-J081-304 Study
  2. Patients who have provided a written informed consent to participate in this clinical trial until the evaluation of week 12 of the E2080-J081-304 Study

Exclusion criteria;

  1. Patients who were judged by the investigator that they are unfit to participate in this clinical study for safety reasons based on the information up to the evaluation of week 12 of the E2080-J081-304 Study.
  2. Patients who were judged by the investigator that they are likely to become non-compliant with administration during the clinical trial period.
  3. Patients who were judged by the investigator that they were unfit to participate in this clinical trial.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151540

Locations
Japan
Nagoyashi, Aichi, Japan
Matsuyama, Ehime, Japan
Fukuoka-shi, Fukuoka, Japan
Hiroshima-shi, Hiroshima, Japan
Sapporo-shi, Hokkaido, Japan
Kobe-shi, Hyogo, Japan
Yokohama, Kanagawa, Japan
Goshi^shi, Kumamoto, Japan
Iwamuma-shi, Miyagi, Japan
Omura, Nagasaki, Japan
Nara-shi, Nara, Japan
Niigata-shi, Niigata, Japan
Yufu-shi, Oita, Japan
Neyagawa-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Moriyama-shi, Shiga, Japan
Shizuoka-shi, Shizuoka, Japan
Kodaira, Tokyo, Japan
Kokubunji-shi, Tokyo, Japan
Shinjuku, Tokyo, Japan
Toyoma-shi, Toyama, Japan
Okayama, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Hiroki Takano Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01151540     History of Changes
Other Study ID Numbers: E2080-J081-305
Study First Received: June 14, 2010
Last Updated: February 20, 2014
Health Authority: JAPAN: Health, Labour and Welfare Ministry

Keywords provided by Eisai Inc.:
Epilepsy
Seizures

Additional relevant MeSH terms:
Intellectual Disability
Spasms, Infantile
Brain Diseases
Central Nervous System Diseases
Epilepsy
Epilepsy, Generalized
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014