Does BRV Have Faster Onset Time & Greater Effect Than LEV in Epilepsy Pts Using PPR Pharmacodynamic Efficacy Endpoint

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to see whether brivaracetam has a faster onset time and greater effect than levetiracetam in subjects with photosensitive seizures. Part 1 of the study will compare the effects of levetiracetam 1500 mg with the effects of brivaracetam 100 mg. Part 2, will compare the effects of levetiracetam 1500 mg with the effects of brivaracetam 100 mg or will compare the effects of levetiracetam 500mg with the effects of brivaracetam 25 mg.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rosenfeld, William E., M.D.
• Collaborators: Comprehensive Epilepsy Care Center for Children & Adults; PRA Health Sciences; UCB Biopharma S.P.R.L.; Utrecht University

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