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Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00504881
First received: July 19, 2007
Last updated: September 5, 2012
Last verified: September 2012
History of Changes

July 19, 2007
September 5, 2012
October 2007
November 2008   (final data collection date for primary outcome measure)
Number of subjects with at least one adverse event during the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
Number of subjects with at least one adverse event during the 16-week Treatment Period
To assess the safety and tolerability of brivaracetam during 16 weeks of treatment in subjects suffering from localization-related epilepsy or generalized epilepsy. [ Time Frame: 16 weeks ]
Complete list of historical versions of study NCT00504881 on ClinicalTrials.gov Archive Site
  • Partial onset seizure (Type I) frequency per week over the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Partial onset seizure (Type I) frequency per week over the 16-week Treatment Period
  • Responder rate for partial onset seizures (Type I) frequency per week over the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Responder rate for partial onset seizures (Type I) frequency per week over the 16-week Treatment Period
  • Seizure frequency (all seizure types) per week over the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Seizure frequency (all seizure types) per week over the 16-week Treatment Period
  • Percent change from Baseline to the 16-week Treatment Period in partial onset seizure (Type I) frequency per week [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Percent change from Baseline to the 16-week Treatment Period in partial onset seizure (Type I) frequency per week
  • Categorized percentage change from Baseline in seizure frequency for partial onset seizure (Type I) over the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Categorized percentage change from Baseline in seizure frequency for partial onset seizure (Type I) over the 16-week Treatment Period
  • Seizure freedom rate (all seizure types) over the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Seizure freedom rate (all seizure types) over the 16-week Treatment Period
  • Reduction of Type IC/Type I seizure frequency ratio from Baseline to the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Reduction of Type IC/Type I seizure frequency ratio from Baseline to the 16-week Treatment Period
  • Time to first Type I seizure during the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Time to first Type I seizure during the 16-week Treatment Period
  • Time to fifth Type I seizure during the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Time to fifth Type I seizure during the 16-week Treatment Period
  • Time to tenth Type I seizure during Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Time to tenth Type I seizure during the 16-week Treatment Period
  • Change from Baseline to the 16-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Change from Baseline to the 16-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score
  • Change from Baseline to the 16-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Change from Baseline to the 16-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score
  • Change from Baseline to the 16-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Change from Baseline to the 16-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score
  • Change from Baseline to the 16-week Treatment Period in Hospital Anxiety score [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Change from Baseline to the 16-week Treatment Period in Hospital Anxiety score
  • Change from Baseline to the 16-week Treatment Period in Hospital Depression score [ Time Frame: Baseline to 16-week Treatment Period ] [ Designated as safety issue: No ]
    Change from Baseline to the 16-week Treatment Period in Hospital Depression score
  • Patient's Global Evaluation Scale (P-GES) evaluated at last visit or early discontinuation visit [ Time Frame: Baseline to last visit or early discontinuation visit in the 16-week Treatment Period ] [ Designated as safety issue: No ]
    Patient's Global Evaluation Scale (P-GES) evaluated at last visit or early discontinuation visit
  • Investigator's Global Evaluation Scale (I-GES) evaluated at last visit or early discontinuation visit [ Time Frame: Baseline to last visit or early discontinuation visit in the 16-week Treatment Period ] [ Designated as safety issue: No ]
    Investigator's Global Evaluation Scale (I-GES) evaluated at last visit or early discontinuation visit
To confirm the efficacy of brivaracetam during 16 weeks of treatment in reducing the partial onset seizure frequency, to assess its effect on the patients Health-related quality of life and to assess its efficacy in reducing seizure days in the epileptic [ Time Frame: 16 weeks ]
Not Provided
Not Provided
 
Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suffering From Localization-related or Generalized Epilepsy.

This study will compare the safety and efficacy of brivaracetam at flexible dose with placebo in subjects suffering from epilepsy.
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, morning and evening, of placebo in a double-blinded way for the 16-week treatment period
  • Drug: Brivaracetam
    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
  • Placebo Comparator: Placebo
    Matching placebo tablets administered twice a day
    Intervention: Drug: Placebo
  • Experimental: Brivaracetam
    A flexible dose of brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
    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
480
December 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects were aged from 16 to 70 years, inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted.
  • Subjects had well-characterized localization-related epilepsy or generalized epilepsy according to the International League Against Epilepsy (ILAE) classification
  • For subjects suffering from localization-related epilepsy: subjects had at least 2 partial-onset seizures (POSs) whether or not secondarily generalized per month during the 3 months preceding Visit 1 according to the ILAE classification
  • For subjects suffering from localization-related epilepsy: subjects had at least 4 partial-onset seizures (POSs) whether or not secondarily generalized during the 4-week baseline period according to the ILAE classification
  • For subjects suffering from generalized epilepsy: subjects had at least 2 Type II-seizure days per month during the 3 months preceding Visit 1 according to the ILAE classification
  • For subjects suffering from generalized epilepsy: subjects had at least 4 Type II-seizure days during the 4 week baseline period according to the ILAE classification
  • Subjects were uncontrolled while treated by 1 to 3 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED.

Exclusion Criteria:

  • For subjects who suffered from localization-related epilepsy: history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 2 or occurring only as Type IA non-motor
  • Subjects with a history or presence of status epilepticus during the year preceding Visit 1 or during baseline
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Czech Republic,   Germany,   Hong Kong,   India,   Italy,   Korea, Republic of,   Norway,   Russian Federation,   Singapore,   South Africa,   Sweden,   Taiwan,   Ukraine
 
NCT00504881
N01254, 2006-006346-34
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
September 2012

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