4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures. |
|---|---|
| Condition | Epilepsy |
| Intervention | Drug: Perampanel |
| Phase | Phase 2 |
| Sponsor | Eisai Inc. |
| Responsible Party | Eisai Inc. |
| ClinicalTrials.gov Identifier | NCT00368472 |
| First Received | August 22, 2006 |
| Last Updated | April 7, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 22, 2006 |
|---|---|
| Last Updated Date | April 7, 2014 |
| Start Date | October 2006 |
| Estimated Primary Completion Date | May 2014 |
| Current Primary Outcome Measures | Seizure frequency per 28 days [Time Frame: baseline (study 206 or 208) to end of treatment] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | incidence rates of treatment-emergent adverse events [Time Frame: baseline (study 206 or 208) to end of treatment] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | 4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures |
|---|---|
| Official Title | A 4-Year Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 as an Adjunctive Therapy in Patients With Refractory Partial Seizures |
| Brief Summary | The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures. |
| Detailed Description | This is an Open-Label Extension (OLE) study for patients who completed the E2007-A001-206 or the E2007-G000-208 double-blind, placebo-controlled, dose-escalation, parallel-group studies. For those patients who have completed E2007-A001-206 study, the 207 study will consist of the following phases during the OLE: 1. OLE Titration Phase (4 weeks): Scheduled visits will be conducted every two weeks for 4 weeks. During this phase, the Investigators will start the E2007 dosing at 2 mg and escalate to 4 mg in two weeks based on patient tolerability and safety. 2. OLE Maintenance Phase (208 weeks): Scheduled visits will be conducted one month following the completion of OLE titration phase and every 3 months thereafter for a total of 208 weeks. During this phase, patients will continue the highest tolerated dose of E2007 that was established during the OLE Titration Phase. 3. OLE Safety Phase (one visit): The purpose of this visit (Week 216) is a four-week follow up after the last dose of study drug was administered. For those patients who have completed E2007-G000-208 study, the 207 study will consist of the following phases during the OLE: 1. OLE Titration Phase (12 weeks): Scheduled visits will be conducted every two weeks for 12 weeks. Titration will be made in 2 weeks intervals, on the basis of individual tolerance and in 2 mg incremental steps (ie, the patients will titrate from 2 mg to 4 mg to 6 mg to 8 mg to 10 mg to 12 mg). 2. OLE Maintenance Phase (208 weeks): Scheduled visits will be conducted one month following the completion of OLE titration phase and every 3 months thereafter for a total of 208 weeks. During this phase, patients will continue the highest tolerated dose of E2007 that was established during the OLE Titration Phase. 3. OLE Safety Phase (one visit): The purpose of this visit (Week 224) is a four-week follow up after the last dose of study drug was administered. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Epilepsy |
| Intervention | Drug: Perampanel perampanel 2 mg - 12 mg, once daily |
| Study Arm (s) | Other: Perampanel |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 108 |
| Estimated Completion Date | May 2014 |
| Estimated Primary Completion Date | March 2014 |
| Eligibility Criteria | KEY INCLUSION CRITERIA: 1. Have completed all scheduled visits up to and including Visit 8 in the E2007-A001-206 study or Visit 9 of the E2007-G000-208 study. 2. Are reliable and willing to make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events. 3. Females of childbearing potential must continue practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or Intrauterine device (IUD)) and for two months after the end of the OLE study. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (e.g., a barrier method plus spermicide, or IUD. 4. Are between the ages of 18 and 70 years of age, inclusive. 5. Are at least 40 kg (88 lb) of weight. 6. Are currently being treated with a stable dose of one, or a maximum of three licensed Anti-epileptic drugs (AEDs) and are known to take their medication(s) as directed. KEY EXCLUSION CRITERIA: 1. Show evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.,) that, in the opinion of the Investigator(s), could affect the patient's safety or trial conduct. 2. Show evidence of significant active hepatic disease and/or bilirubin > 1.5 mg/dL. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less than two times the upper limit of normal (ULN). 3. Show evidence of significant active hematological disease. White blood cell (WBC) count cannot be ? 2500/?L (2.50 1E+09/L) or an absolute neutrophil count ? 1000/?L (1.00 1E+09/L). 4. Clinically significant ECG abnormality, including prolonged QTc (defined as ? 450 msec). 5. Presence of major active psychiatric disease. Patients taking a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Australia, Belgium, Czech Republic, Estonia, Finland, France, Germany, Latvia, Lithuania, Netherlands, Spain, Sweden, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00368472 |
|---|---|
| Other Study ID Numbers | E2007-A001-207 |
| Has Data Monitoring Committee | No |
| Information Provided By | Eisai Inc. |
| Study Sponsor | Eisai Inc. |
| Collaborators | Not Provided |
| Investigators | Study Director: Michelle Gee, PhD Eisai Limited |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| University of Alabama at Birmingham | Birmingham, Alabama, United States, 35294 |
|---|---|
| St. Joseph's Hospital Medical Center | Phoenix, Arizona, United States, 85013 |
| Clinical Trials Inc | Little Rock, Arkansas, United States, 72205 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas, United States, 72205 |
| Mile High Research Center | Denver, Colorado, United States, 80218 |
| Bradenton Research Center, Inc. | Bradenton, Florida, United States, 34205 |
| Melbourne Internal Medicine Associates | Melbourne, Florida, United States, 32901 |
| Emory University | Atlanta, Georgia, United States, 30322 |
| John Hopkins Hospital | Baltimore, Maryland, United States, 21287 |
| Long Island Jewish Medical Center | New Hyde Park, New York, United States, 11040 |
| The Ohio State University | Columbus, Ohio, United States, 43210 |
| Epilepsy and Neurodevelopment, Inc. | West Jordan, Utah, United States, 84088 |
| Fletcher Allen Health Care | Burlington, Vermont, United States, 05401 |
| Strategic Health Evaluators | Chatswood, New South Wales, Australia, 2067 |
| North Coast Neurology Centre | Maroochydore, Queensland, Australia, 4558 |
| Central Northern Adelaide Health Service Inc. | Woodville, South Australia, Australia, 5011 |
| UZ Antwerpen | Edegem, Belgium, 2650 |
| UZ Gent | Gent, Belgium, 9000 |
| UZ Leuven | Leuven, Belgium, B-3000 |
| Sint-Andriesziekenhuis | Tielt, Belgium, B-8700 |
| Fakultni nemocnice u sv. Anny v Brne | Brno, Czech Republic, 656 91 |
| Fakultni nemocnice Hradec Kralove | Hradec Kralove, Czech Republic, 500 05 |
| Fakultni Nemocnice Olomouc | Olomouc, Czech Republic, 775 20 |
| Cerebrovaskularni poradna s.r.o. | Ostrava, Czech Republic, 708 52 |
| Fakultni nemocnice v Motole | Praha 5, Czech Republic, 150 06 |
| CTC Rychnov nad Kneznou s.r.o. | Rychnov nad Kneznou, Czech Republic, 516 01 |
| West Tallinn Central Hospital | Tallinn, Estonia, 10617 |
| Tartu University Hospital | Tartu, Estonia, EE-51014 |
| Kuopion Yliopistollinen sairaala | Kuopio, Finland, FI-70210 |
| FinnMedi Oy | Tampere, Finland, FI-33520 |
| Hopital Roger Salengro | Lille, France, 59037 |
| Hopital Gui de Chauliac | Montpellier, France, 34295 |
| Cabinet Medical du Dr Contis | Ramonville Saint-Agne, France, 31520 |
| Institut fur Diagnostik der Epilepsien gGmbH am Epilepsie-ZentrumBerlin-Brandenburg | Berlin, Germany, D-10365 |
| Universitat-Georg-August | Gottingen, Germany, 37075 |
| Studienzentrum Dr. Arnold | Munchen, Germany, 80333 |
| Universitatsklinikum Ulm | Ulm, Germany, 89081 |
| Pauls Stradins Clinical University Hospital | Riga, Latvia, LV-1002 |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas, Lithuania, LT-50009 |
| Neuromeda | Kaunas, Lithuania, LT-50185 |
| Klaipeda University Hospital | Klaipeda, Lithuania, LT-92288 |
| Republican Siauliai Hospital | Siauliai, Lithuania, LT-76231 |
| Vilnius University Hospital Santariskiu Klinikos | Vilnius, Lithuania, LT-08661 |
| M. Marcinkevicius Hospital | Vilnius, Lithuania, LT-03215 |
| Stichting Epilepsie Instellingen Nederland | Rotterdam, Netherlands, 3012 KM |
| Hospital Universitario La Fe | Valencia, Spain, 46009 |
| Neuro Center | Stockholm, Sweden, 112 45 |
| Ninewells Hospital | Dundee, United Kingdom, DD1 9SY |