Canabidiol (CBD) for Treatment of Frontal Lobe Epilepsy
Phase 3
- Conditions
- Treatment Resistant Epilepsy.Epilepsy and recurrent seizures
- Registration Number
- IRCT20210608051515N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Drug resistant frontal lobe epilepsy diagnosis (Insufficient or no response to two or more of anti epileptic agents)
Exclusion Criteria
Consumption of any derivative of marijuana or cannabis plant in recent month
Pregnancy
Any of the aforementioned medications in regimen: Clobazam, DesMethyl Clobazam, Eslicarbazepin, Topiramate, Zonisamide, Warfarin
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in the seizure frequency in drug-resistant frontal lobe epilepsy following cannabidiol use. Timepoint: Before the intervention and after 14 weeks of taking the drug or placebo. Method of measurement: Based on the patient's history and counting the number of seizures per month.
- Secondary Outcome Measures
Name Time Method Decrease in the severity of seizures after taking cannabidiol according to the Chalfont seizure severity scale. Timepoint: Before the intervention and after fourteen weeks of taking drug or placebo. Method of measurement: Based on the Chalfont seizure severity by scoring system.;Increase in quality of life in epilepsy following cannabidiol use. Timepoint: Before the intervention and after the fourteen weeks of taking medication or placebo. Method of measurement: Quality of Life in Epilepsy with 31 questions (QOLIE-31) questionnaire by scoring.