Completed
PHASE3
INTERVENTIONAL
NCT00504881
Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.
Interventions
Name:
Placebo
Type:
DRUG
Description:
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period
Name:
Brivaracetam
Type:
DRUG
Description:
Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period
Primary Outcomes
Measure:
Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period
TimeFrame:
Week 2 to the end of the Treatment Period (Week 16)
Description:
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measure:
Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period
TimeFrame:
Baseline (Week 0) to the end of the Treatment Period (Week 16)
Description:
Partial (Type I) seizures can be classified into one of the following three groups:
* Simple partial seizures
* Complex partial seizures
* Partial seizures evolving to generalized tonic-clonic convulsions.
Partial Onset Seizure (POS) frequency per week over the Treatment Period (TP) was calculated as:
(Total Type I seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP)
Trial Information
NCT ID
NCT00504881
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
UCB Pharma SA
Last Updated
December 15, 2025