Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures (BRITE™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01261325
First received: December 9, 2010
Last updated: May 29, 2014
Last verified: May 2014

December 9, 2010
May 29, 2014
December 2010
May 2014   (final data collection date for primary outcome measure)
  • Percent reduction over placebo for partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
    Primary endpoint: United States of America (FDA)
  • 50% responder rate for partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration [ Time Frame: Baseline to 12 week Treatment Period ] [ Designated as safety issue: No ]
    Primary Endpoint: European Regulatory Authorities
50% responder rate for partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration [ Time Frame: Average over 12 week Treatment Period standardized to a 28-day duration ] [ Designated as safety issue: No ]
Primary Endpoint: European Union Regulatory Authorities
Complete list of historical versions of study NCT01261325 on ClinicalTrials.gov Archive Site
  • Percent reduction in partial onset seizure (Type I) frequency from the Baseline to the Treatment Period [ Time Frame: Baseline to 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Categorized percent reduction form Baseline in seizure frequency for partial onset seizure (Type I) over the Treatment Period [ Time Frame: Baseline to 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Seizure freedom rate (all seizure types) during the 12-week Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
  • All seizure frequency (Type I + II + III) during the 12-week Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Time to the first Type I seizure during the Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Time to the fifth Type I seizure during the Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Time to the tenth Type I seizure during the Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Percent reduction in partial onset seizure (Type I) frequency from the Baseline to the Treatment Period [ Time Frame: Average over 12 week Treatment Period standardized to a 28-day duration ] [ Designated as safety issue: No ]
  • Categorized percent reduction form Baseline in seizure frequency for partial onset seizure (Type I) over the Treatment Period [ Time Frame: Average over 12 week Treatment Period standardized to a 28-day duration ] [ Designated as safety issue: No ]
  • Seizure freedom rate (all seizure types) during the 12-week Treatment Period [ Time Frame: Average over 12 week Treatment Period standardized to a 28-day duration ] [ Designated as safety issue: No ]
  • All seizure frequency (Type I + II + III) during the 12-week Treatment Period [ Time Frame: Average over 12 week Treatment Period standardized to a 28-day duration ] [ Designated as safety issue: No ]
  • Time to the first Type I seizure during the Treatment Period [ Time Frame: Average over 12 week Treatment Period standardized to a 28-day duration ] [ Designated as safety issue: No ]
  • Time to the fifth Type I seizure during the Treatment Period [ Time Frame: Average over 12 week Treatment Period standardized to a 28-day duration ] [ Designated as safety issue: No ]
  • Time to the tenth Type I seizure during the Treatment Period [ Time Frame: Average over 12 week Treatment Period standardized to a 28-day duration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures

This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Epilepsy
  • Drug: Placebo
    Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period
  • Drug: Brivaracetam
    Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period
  • Drug: Brivaracetam
    Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period.
  • Placebo Comparator: Placebo
    Matching placebo tablets administered twice daily
    Intervention: Drug: Placebo
  • Experimental: Brivaracetam 100 mg/ day
    Brivaracetam 50 mg/ day administered twice daily.
    Intervention: Drug: Brivaracetam
  • Experimental: Brivaracetam 200 mg/ day
    Brivaracetam 100 mg/ day administered twice daily
    Intervention: Drug: Brivaracetam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
768
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
  • Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
  • Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years
  • Subjects having at least 8 Type I seizures [POS; focal seizures (according to the 1981 ILAE classification)] during the 8-week Baseline Period with at least 2 Type I seizures during each 4-week interval of the Baseline Period
  • Subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1
  • Subjects being uncontrolled while treated by 1 or 2 permitted concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
  • Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital, phenytoin, and primidone) before V1 and expected to be kept stable during the Baseline and Treatment Period. Benzodiazepine taken more than once a week (for any indication) will be considered as a concomitant AED

Exclusion Criteria:

  • Subject previously randomized within this study or any other prior study with BRV as a dosing arm
  • Seizure type IA (1981 ILAE classification) nonmotor as only seizure type.
  • Subject is currently treated with LEV or has taken LEV within 90 days prior to V1
  • Subject has any medical or psychiatric condition, obvious cognitive impairment or mental retardation that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
  • Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
  • Subject has history or presence of status epilepticus during the year preceding V1 or during Baseline
  • Subject has history or presence of known psychogenic nonepileptic seizures
  • Subject on felbamate with less than 18 months exposure before V1
  • Subject currently on vigabatrin. Subject with history of vigabatrin use but either no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or results of these examinations are abnormal
  • Subject taking any drug with possible central nervous system (CNS) effects except if stable from at least 1 month before V1 and expected to be kept stable during the Treatment Period
  • Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 6 months
  • Subject is suffering from severe cardiovascular disease or peripheral vascular disease
  • Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
  • Subject has ongoing psychiatric disease other than mild controlled disorder
Both
16 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Estonia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom
 
NCT01261325
N01358, 2010-019361-28
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP