Trial record 13 of 17 for:
Lennox-Gastaut Syndrome
A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01151540
First received: June 14, 2010
Last updated: December 27, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
Lennox-Gastaut syndrome
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 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;
- Patients who have completed the evaluation of week 12 of the E2080-J081-304 Study
- 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;
- 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.
- Patients who were judged by the investigator that they are likely to become non-compliant with administration during the clinical trial period.
- Patients who were judged by the investigator that they were unfit to participate in this clinical trial.
Contacts and Locations
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: | December 27, 2012 |
| Health Authority: | JAPAN: Health, Labour and Welfare Ministry |
Keywords provided by Eisai Inc.:
|
Epilepsy Seizures |
Additional relevant MeSH terms:
|
Mental Retardation Spasms, Infantile Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Mental Disorders Diagnosed in Childhood Mental Disorders Epilepsy, Generalized Epilepsy Brain Diseases Central Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013