Does BRV Have Faster Onset Time & Greater Effect Than LEV in Epilepsy Pts Using PPR Pharmacodynamic Efficacy Endpoint
Completed · Phase 2/Phase 3
Conditions studied: Photosensitive Epilepsy
In brief
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.
Key facts
- Study ID
- NCT03580707
- Run by
- Rosenfeld, William E., M.D.
- People needed
- 16
- Starts
- 2018-06-01
- Expected to finish
- 2018-12-31
- Last updated by the study team
- 2019-03-26
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Comprehensive Epilepsy Care Center For Children And Adults — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.