Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Epilepsy
Interventions
DRUG

Brivaracetam tablets

100 mg, intake twice daily (BID) for 7 days during Run-In Period

DRUG

Brivaracetam bolus

10 mL (= 100 mg) of Brivaracetam administered intravenously over 2 minutes twice daily (BID) during Evaluation Period

DRUG

Brivaracetam infusion

10 mL (= 100 mg) of Brivaracetam diluted in 90 mL 0.9 % isotonic saline sterile solution for intravenous administration infused over 15 minutes twice daily (BID) during Evaluation Period

OTHER

Placebo

100 mg twice daily (BID) for 7 days during Run-In Period

Trial Locations (17)

Unknown

001, Phoenix

775, Little Rock

780, Lexington

008, Bethesda

778, Columbus

776, Nashville

777, Dallas

036, Charlottesville

917, Brno

915, Hradec Králové

916, Kroměříž

913, Ostrava Poruba

332, Bielefeld

903, Bonn

795, Katowice

479, Poznan

794, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY

NCT01405508 - Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy | Biotech Hunter | Biotech Hunter