Fenosha study
Phase 3
- Conditions
- Epilepsy.Epilepsy and recurrent seizures
- Registration Number
- IRCT20120703010178N17
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Age older than 15 years old
Take one or two anti-epileptic drugs at least 2 months before entering the study
At least 1 seizure per month for 3 consecutive months
Patient agrees to enter the study
Exclusion Criteria
Simple partial epilepsy without motor symptoms
Known and progressive neurological disorder
Status or cluster epilepsy within 3 months before entering the study
History of psychogenic epilepsy in the last 2 years
Uncontrolled illness or drug use associated with impaired Lab data (liver enzyme at least twice upper limit of normal or Creatinine clearance less than 50 ml / min)
Non compliance
Pregnancy or breastfeeding
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seizure frequency. Timepoint: 30, 60, 90 days. Method of measurement: Patient and families's remarks.
- Secondary Outcome Measures
Name Time Method Safety and adverse drug reactions. Timepoint: 30, 60, 90 days. Method of measurement: Patient's remarks.