Does BRV Have Faster Onset Time & Greater Effect Than LEV in Epilepsy Pts Using PPR Pharmacodynamic Efficacy Endpoint
Photosensitive Epilepsy
About this trial
This is an interventional treatment trial for Photosensitive Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Patients between 18 and 65 years of age
- Male or female
- PPR at minimum at 60,50,40,30,25,20,18 or 16 Hz as upper threshold
- Drug naïve or at most with up to 4 AEDs, not being LEV or BRV
Exclusion Criteria:
- Current treatment with more than 4 AEDs
- LEV or BRV as current treatment or used in the previous month.
- History of severe side-effects or psychological side-effects with LEV or BRV use
- Being pregnant or insufficiently protected against pregnancy (see also ref 31) or lactating Female
- Serious internal medical disease (renal/hepatic/cardiovascular disease) as deemed by the on-site physician (WER)
- History of psychiatric disease that has been a reason for acute hospitalisation for their condition of depression, schizophrenia, mania, delirium or aggressive behaviour
- History of status epilepticus
- History of significant ethanol or illicit drug use
Sites / Locations
- The Comprehensive Epilepsy Care Center For Children And Adults
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Part 1
Part 2
Compare rapidity of CNS effects of levetiracetam (LEV) & brivaracetam (BRV) within same pt-(randomized, two-way crossover, dbl-blind in total 16 pts w/epilepsy. Pt 1: IV infusion over 15 min BRV will also be administered as 15-min.infusion. BRV vs LEV in randomized double blinded, crossover fashion.
Pt 2 Op I:Assuming statistically signify. diff. in rapidity of CNS action has been observed from an analysis of data set in Pt 1,will proceed w/ Pt 2Opt I. Levetiracetam (LEV) or brivaracetam (BRV administered in randomized, two-way crossover, dbl-blind design as IV infusion over 5 min. to another cohort of 8 pts w/photosensitive epilepsy OR Pt 2,Opt II: Assuming no statistically signif. diff. in rapidity of CNS action has been observed from an analysis of data set in Pt 1, will proceed w/Pt 2,Opt II. LEV or BRV will be administered, in randomized, two-way crossover, dbl-blind design as IV infusion over again 15 min. to another cohort of 8 pts w/ photosensitive epilepsy. LEV will be given as 500 mg dose & BRV as 25 mg dose. BRV vs LEV in randomized double blinded, crossover fashion.