Completed
PHASE3
INTERVENTIONAL
NCT00464269
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.
Interventions
Name:
Placebo
Type:
OTHER
Description:
* Active Substance: Placebo
* Pharmaceutical Form: Film-coated tablet
* Concentration: 2.5 mg, 10 mg and 25 mg
* Route of Administration: Oral use
Name:
Brivaracetam 2.5 mg
Type:
DRUG
Description:
* Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 2.5 mg
* Route of Administration: Oral use
Name:
Brivaracetam 10 mg
Type:
DRUG
Description:
* Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 10 mg
* Route of Administration: Oral use
Name:
Brivaracetam 25 mg
Type:
DRUG
Description:
* Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 25 mg
* Route of Administration: Oral use
Primary Outcomes
Measure:
Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
TimeFrame:
Baseline to 12-week Treatment Period
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
NCT00464269
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
UCB Pharma
Last Updated
December 15, 2025