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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014