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

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ClinicalTrials.gov Identifier: NCT01261325
Recruitment Status : Completed
First Posted : December 16, 2010
Results First Posted : August 15, 2016
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Placebo Drug: Brivaracetam Drug: Antiepileptic drugs with market authorization available per country Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 768 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo tablets administered twice daily
 Drug: Placebo
Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period
Drug: Antiepileptic drugs with market authorization available per country
Experimental: Brivaracetam 100 mg/ day
Brivaracetam 50 mg/ day administered twice daily.
 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: Antiepileptic drugs with market authorization available per country
Experimental: Brivaracetam 200 mg/ day
Brivaracetam 100 mg/ day administered twice daily
 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.
Drug: Antiepileptic drugs with market authorization available per country


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Primary endpoint: United States of America (FDA)

  2. 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 ]
    Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.


Secondary Outcome Measures :
  1. Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period [ Time Frame: Baseline to 12 week Treatment Period ]
  2. 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 ]
  3. Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period [ Time Frame: 12 week Treatment Period ]
  4. All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period [ Time Frame: 12 week Treatment Period ]
  5. Time to the First Type I Seizure During the Treatment Period [ Time Frame: 12 week Treatment Period ]
  6. Time to the Fifth Type I Seizure During the Treatment Period [ Time Frame: 12 week Treatment Period ]
  7. Time to the Tenth Type I Seizure During the Treatment Period [ Time Frame: 12 week Treatment Period ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261325


  Show 207 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Product Information  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01261325     History of Changes
Other Study ID Numbers: N01358
2010-019361-28 ( EudraCT Number )
First Posted: December 16, 2010    Key Record Dates
Results First Posted: August 15, 2016
Last Update Posted: January 8, 2018
Last Verified: December 2017

Keywords provided by UCB Pharma:
Epilepsy
Brivaracetam
Partial Onset Seizures
Adjunctive treatment

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Brivaracetam
Anticonvulsants