NCT01405508

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

A Multi-center, Open-label, Four-arm, Randomized Trial Evaluating the Safety and Tolerability of Brivaracetam Intravenous Infusion and Bolus, Administered in BID Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 70 Years Suffering From Epilepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with epilepsy according to an initiation or a conversion scheme, during repeated dosing (100 mg/administration twice daily for 4.5 days).

Detailed description

Eligible subjects will be randomized in a 1:1:1:1 ratio to the 4 treatment arms

Conditions

• Epilepsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-07-29
• Last updated: 2018-07-11
• Results posted: 2016-04-13

Locations

17 sites across 4 countries: United States, Czechia, Germany, Poland