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: December 3, 2013
Last verified: December 2013
  Purpose

This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.


Condition Intervention Phase
Epilepsy
Drug: Placebo
Drug: Brivaracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 480
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching Placebo tablets administered twice a day
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
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
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

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504881

  Show 63 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided by UCB, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00504881     History of Changes
Other Study ID Numbers: N01254, 2006-006346-34
Study First Received: July 19, 2007
Last Updated: December 3, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Austria: Federal Ministry for Health Family and Youth
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
India: Central Drugs Standard Control Organization
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Norway: Norwegian Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Taiwan: National Bureau of Controlled Drugs
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by UCB, Inc.:
Epilepsy
Brivaracetam
Partial Onset Seizures

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Generalized
Stress, Psychological
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014