A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
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:
NCT00903786
First received: May 15, 2009
Last updated: November 16, 2012
Last verified: November 2012
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Purpose
The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Partial Seizures |
Drug: perampanel |
Phase 2 |
| 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 E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs) |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Perampanel
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 [ Time Frame: 4 weeks, 8 weeks, 16 weeks and every 12 weeks till approval ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluation of patient diaries for seizures [ Time Frame: 4 weeks, 8 weeks, 16 weeks and every 12 weeks till approval ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Perampanel 2 mg |
Drug: perampanel
Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.
|
Eligibility| Ages Eligible for Study: | 20 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients who consent to the study entry on their free will before starting any trial-related activities.
- Patients who participated in Study 231 and completed the required evaluation period (10 weeks).
- Patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. Patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator.
Exclusion criteria:
- Pregnant or lactating women, women of child-bearing potential, women willing to become pregnant.
- Patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period.
- Patients who operate heavy equipment or drive should not be recruited into the study.
- Patients who are ineligible for study entry judged by the investigator or sub-investigator.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903786
Locations
| Japan | |
| Kitakyusyu, Fukuoka, Japan | |
| Kobe, Hyogo, Japan | |
| Sendai, Miyagi, Japan | |
| Komatsushima, Tokushima, Japan | |
| Kodaira, Tokyo, Japan | |
| Kyoto, Japan | |
| Nagasaki, Japan | |
| Niigata, Japan | |
| Shizuoka, Japan | |
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
| Study Director: | Kazunori Saeki | Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd. |
More Information
No publications provided
| Responsible Party: | Eisai Inc. ( Eisai Co., Ltd. ) |
| ClinicalTrials.gov Identifier: | NCT00903786 History of Changes |
| Other Study ID Numbers: | E2007-J081-233 |
| Study First Received: | May 15, 2009 |
| Last Updated: | November 16, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Eisai Inc.:
|
Seizure epilepsy |
Additional relevant MeSH terms:
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations |
Signs and Symptoms Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013