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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

June 1, 2018

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Photosensitive Epilepsy
Interventions
DRUG

BRV vs LEV in randomized double blinded, crossover fashion

Single dose intravenous administration of BRV 100 mg over a 15 minutes period. On a subsequent occasion, (approximately 2 weeks later), the patient is crossed over to the other drug at a singular dose. On both occasions, intermittent photic stimulation is done 10 times in a two hour period. IPS is again conducted in the cross over portion as well. Coincident with IPS stimulation 10 blood samples will be drawn for BRV or LEV plasma concentration.

Trial Locations (1)

63141

The Comprehensive Epilepsy Care Center For Children And Adults, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Comprehensive Epilepsy Care Center for Children & Adults

OTHER

collaborator

Utrecht University

OTHER

collaborator

PRA Health Sciences

INDUSTRY

collaborator

UCB Biopharma S.P.R.L.

INDUSTRY

lead

Rosenfeld, William E., M.D.

INDIV

NCT03580707 - Does BRV Have Faster Onset Time & Greater Effect Than LEV in Epilepsy Pts Using PPR Pharmacodynamic Efficacy Endpoint | Biotech Hunter | Biotech Hunter