An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study
Not Applicable
- Conditions
- Patients diagnosed with Focal Onset Seizures
- Registration Number
- JPRN-UMIN000044131
- Lead Sponsor
- International University of Health and Welfare and Eisai Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) A history of receiving any AED (including AED used as rescue treatment) for more than 2 weeks in total within 2 years 2) Previously treated with perampanel at any time 3) A history of hypersensitivity to any of the excipients of perampanel 4) Severe hepatic impairment(Child-Pugh Score:C) 5) Subjects who have participated in a study involving administration of an investigational drug/biologics or device within 4 weeks 6) Not appropriate for the study according to the judgment of the investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method