Epilepsy: refractory partial seizures with or without secondary generalisation
Conditions
Sponsors
Eisai Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have completed Visit 8 of study E2007-G000-304, E2007-G000-305 study, or E2007-G000-306 and shown compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences). 2. Provide written informed consent signed by subject or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained); 3. Be considered reliable and willing to be available for the study period and able to record seizures and report adverse events them self or have a caregiver who can record and report the events for them. 4. Females should be either of nonchildbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. For females of childbearing potential, they must agree to be abstinent or continue using at least 1 medically acceptable methods of contraception (eg, a double-barrier method [eg, condom + spermicide, condom + diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the entire study period and for 2 months after the last dose of study drug. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (as described previously) throughout the entire study period and for 2 months after the last dose of study drug. (It is not required for male subjects to use contraceptive measures based on preclinical toxicology data). 5. Continue to be treated with a stable dose of 1 or a maximum of 3 approved AEDs. Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Those who, for any reason, discontinued early from the preceding double-blind study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety and tolerability of perampanel (up to12mg/day) given as adjunctive treatment in subjects with refractory partial seizures;Secondary Objective: The secondary objective is to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.;Primary end point(s): For subjects who were assigned to the perampanel treatment arms during the preceding double-blind studies, the following variables will be analyzed over the Double-blind Phase plus the Open-label Treatment Phase (Conversion Period + Maintenance Period) relative to Pre-randomization Phase of the double-blind study. For subjects who were assigned to the placebo arms during the double-blind studies, the following variables will only be analyzed over the Open-label Treatment Phase (Conversion Period + Maintenance Period) relative to Pre-randomization Phase of the double-blind study: 1. Percent change in seizure frequency per 28 days 2. Proportion of patient who experience a 50% or greater reduction in seizure frequency per 28 days (responder rate analysis) 3. Percent change in seizure frequency per 28 days per seizure type | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed