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Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
This study has been completed.

First Received on June 21, 2007.   Last Updated on September 2, 2011   History of Changes
Sponsor: UCB, Inc.
Information provided by (Responsible Party): UCB, Inc.
ClinicalTrials.gov Identifier: NCT00490035
  Purpose

This study will evaluate the efficacy and safety of brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Condition Intervention Phase
Epilepsy
 Other: Placebo
Drug: Brivaracetam
 Phase III

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: A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Brivaracetam
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Partial onset seizure (Type I) frequency per week over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Partial onset seizure (Type I) frequency per week over the 12-week Treatment Period


Secondary Outcome Measures:
  • Responder rate for partial onset seizures (Type I) frequency per week over the 12-week Treatment period [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Responder rate for partial onset seizures (Type I) frequency per week over the 12-week Treatment period

  • All seizure frequency (Type I+II+III) per week over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    All seizure frequency (Type I+II+III) per week over the 12-week Treatment Period

  • Percent change from baseline to the 12-week treatment period in partial onset seizure (Type I) frequency per week [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Percent change from baseline to the 12-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 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Categorized percentage change from Baseline in seizure frequency for partial onset seizure (Type I)over the 12-week Treatment Period

  • Seizure freedom rate (all seizure types) over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
    Seizure freedom rate (all seizure types) over the 12-week Treatment Period

  • Time to first Type I seizure during the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Time to first Type I seizure during the 12-week Treatment Period

  • Time to fifth Type I seizure during the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Time to fifth Type I seizure during the 12-week Treatment Period

  • Time to tenth Type I seizure during the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Time to tenth Type I seizure during the 12-week Treatment Period

  • Reduction of Type IC/Type I seizure frequency ratio from baseline to the 12- week treatment period. [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Reduction of Type IC/Type I seizure frequency ratio from baseline to the 12- week treatment period.

  • Change from baseline to the 12-week treatment period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Change from baseline to the 12-week treatment period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score

  • Change from baseline to the12-week treatment period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Change from baseline to the12-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 12-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 12-week Treatment period ] [ Designated as safety issue: No ]
    Change from baseline to the 12-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 12-week treatment period in Hospital Anxiety score [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Change from baseline to the 12-week treatment period in Hospital Anxiety score

  • Change from baseline to the 12-week treatment period in Hospital Depression score [ Time Frame: Baseline to 12-week Treatment period ] [ Designated as safety issue: No ]
    Change from baseline to the 12-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 12-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 12-week Treatment period ] [ Designated as safety issue: No ]
    Investigator's Global Evaluation Scale (I-GES) evaluated at last visit or early discontinuation visit


Enrollment: 399
Study Start Date: September 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching Placebo tablets administered twice a day
 Other: Placebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment period
Experimental: Brivaracetam 20 mg/day
Brivaracetam 20 mg/day, 10 mg administered twice a day
 Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment period
Experimental: Brivaracetam 50 mg/day
Brivaracetam 50 mg/day, 25 mg administered twice a day
 Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment period.
Experimental: Brivaracetam 100 mg/day
Brivaracetam 100 mg/day, 50 mg administered twice a day
 Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-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 from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted.
  • Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
  • Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification).
  • Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1.

Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period.

  • Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drug (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED.

Exclusion Criteria:

  • History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3.
  • 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: NCT00490035

  Show 77 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

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00490035     History of Changes
Other Study ID Numbers: N01252, 2006-006344-59
Study First Received: June 21, 2007
Last Updated: September 2, 2011
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Netherlands: Medicines Evaluation Board (MEB);   Poland: Ministry of Health;   Switzerland: Swissmedic;   Hungary: National Institute of Pharmacy;   India: Drugs Controller General of India

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

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

ClinicalTrials.gov processed this record on February 09, 2012



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