Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
- Conditions
- Health Condition 1: null- Refractory partial seizures
- Registration Number
- CTRI/2009/091/000561
- Lead Sponsor
- Eisai Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 1430
Each subject must meet all of the following criteria to be enrolled in this study:
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 [more than 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 provided in Section 1.3 of Protocol).
5. Continue to be treated with a stable dose of 1 or a maximum of 3 approved AEDs.
Subjects who meet the following criteria will be excluded from the study:
1. Those who, for any reason, discontinued early from the preceding double-blind study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy will be assessed by seizure counts (using subjects diaries) documenting the percent change in seizure frequency per 28 days.Timepoint: Time Frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts between visits. After 16 wks, they will be done every 12 wks w/interim telephone contacts in between. <br/ ><br> <br/ ><br>Designated as safety issue: No <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary efficacy measures will evaluate the delayed treatment effect by summarizing previous endpoints over the open-label treatment phase relative to the pre-randomization phase of the double-blind study.Timepoint: Time Frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts. After 16 weeks, they will be done every 12 wks w/interim telephone contacts in between. <br><br>Designated as safety issue: No