E2007 is given as adjunctive, long-term treatment in patients with refractory partial onset seizures with or without secondary generalization
Conditions
Interventions
Product Name: MARS
Product Code: E2007
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Perampanel
Current Sponsor code: E2007
Other descriptive name: MARS
Concentration unit: mg milligra
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent signed by the patient or legal guardian prior to entering the OLE study or undergoing any study procedures. 2. 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 (revised per Amendment 04 and A). 3. 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. 4. Male and female patients will be eligible for enrollment. Females of childbearing potential must continue practicing a medically acceptable method of contraception (eg, abstinence, a barrier method plus spermicide, or IUD) and for 8 weeks after the end of the study. (revised per Amendment 06) Those women using hormonal contraceptives must also continue using an additional approved method of contraception (eg, a barrier method plus spermicide, or IUD) starting with the Titration Phase and continuing throughout the entire study period (revised per Amendments 02 and 06). 5. Are between the ages of 18 and 70 years of age, inclusive. 6. Are at least 40 kg (88 lb) in weight (revised per amendment 06). 7. Are currently being treated with a stable dose of one, or a maximum of three, marketed and approved AEDs and are known to take their medication(s) as directed (revised per Amendment 04 and A). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 192 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 = 450 msec). (revised per Amendments 03, 04 and A). 5. Presence of major active psychiatric disease. Patients taking a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed (revised per Amendment 03).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is to evaluate the safety and tolerability of E2007 given as adjunctive, long-term treatment in patients with refractory partial onset seizures with or without secondary generalization that completed the E2007-A001-206 or the E2007-G000-208 study.(revised per Amendments 04, A, and 06);Secondary Objective: The secondary objective for this study is to evaluate the long-term maintenance of E2007 efficacy for the control of partial onset seizures by the change in partial seizure frequency from Baseline in the E2007-A001-206 or E2007-G000-208 studies to the last efficacy collecting visit of the E2007-A001-207 study. (revised per Amendments 02, 04, A and 07);Primary end point(s): Safety of open-label study population exposed to E2007 in partial epilepsy patients with refractory seizures with or without secondary generalization will be examined based on nature, frequency, and severity of adverse events, vital signs, physical and neurological examination findings, 12-lead ECG abnormalities and chemistry and hematology laboratory test results.;Timepoint(s) of evaluation of this end point: Titration phase, maintenance phase up to week, end of trial/early termination, follow-up phase and unscheduled visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with reduction in partial seizure frequency and median percentage change in partial seizure frequency from the baseline phase to the last efficacy collecting visit will be summarized (revised per amendment 07). Highest tolerated dose given to patients using a flexible titration schedule will be assessed. Highest tolerated dose will be defined as the maximum dose at which a maximum of 20% of the patients experience dose limiting adverse events. To better interpret the results, this self-selecting cohort of patients entering the OLE will be characterized. Demographic variables, median percentage in partial seizures, and percentage of patients with abnormal labs and SAEs will be compared between the patients continuing OLE and patients who stop the study after completing the E2007 A001-206 or the E2007- G000-208 studies (revised per Amendments 04 and A). ;Timepoint(s) of evaluation of this end point: Baseline to last efficacy collecting visit. | — |
Countries
Australia, Belgium, Czech Republic, Estonia, Finland, France, Germany, Latvia, Lithuania, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactMedical Information
Eisai Europe limited
Outcome results
None listed