Safety and Efficacy Study of Adjunctive Brivaracetam

A Phase II open-label, pharmacokinetic safety and efficacy study of the experimental adjunctive drug brivaracetam in children with epilepsy (ClinicalTrials.gov Identifier NCT00422422) is currently recruiting participants. Brivaracetam, an investigational drug chemical structurally similar to levetiracetam, is hoped to exceed the potency of its predecessor while reducing side effects of irritability and other non-psychiatric behavioral adverse events. The first two studies of the agent in a small group of expert sites has been described as "extremely promising.” Two large completed global studies showed efficacy of brivaracetam for doses of 50 mg/day and 100 mg/day. However, one of these two studies failed to show statistical separation from placebo for the primary efficacy end point due to pre-specified testing sequence. A third trial is underway to confirm the efficacy and also explore the higher end of dose-response.

Children between the ages of 1 month and 16 years who have Dravet syndrome and/or who have had not had convulsive status epilepticus within one month prior to the screening visit or during the baseline phase are eligible to participate in the study. The other specified inclusion criteria are: 

• Clinical diagnosis of epilepsy
• Subject having at least 1 seizure (any type) during the 3 weeks before first visit
• Stable dosing of 1-3 concomitant antiepileptic drugs

Exclusion criteria are:

• Pregnant or nursing females
• Concomitant use of Levetiracetam
• Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative disease
• History of status epilepticus (within one month prior to the screening visit or during the baseline phase)
• Clinically significant acute or chronic illness, underlying disease or medication condition
• History of suicide attempt

UCB, Inc., the sponsor of the study, is seeking a total estimated enrollment of 100 participants. The study started in July 2011 and is estimated to be completed in August 2012, with final data collection date for primary outcome measure at that time. The study involves a three-week up-titration period. Patients who are able to complete at least the first week of treatment will have an opportunity to enter a long term follow-up study. Patients who do not transition to long term follow-up study will enter a down-titration period of upto two weeks. Currently, centers in Wellington, Florida and St. Paul, Minnesota are recruiting, with additional centers expected to open for recruiting throughout the United States later this year (visit the ClinicalTrials.gov page for updated recruiting information).

For more information or to apply, contact the UCB Clinical Trial Call Center at (877) 822-9493. Please refer to this study by its ClinicalTrials.gov identifier (NCT00422422).

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