Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00490035
First received: June 21, 2007
Last updated: February 19, 2013
Last verified: February 2013

June 21, 2007
February 19, 2013
September 2007
February 2009   (final data collection date for primary outcome measure)
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
To evaluate the efficacy of brivaracetam in reducing seizure frequency in subjects with partial onset seizures
Complete list of historical versions of study NCT00490035 on ClinicalTrials.gov Archive Site
  • 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 the 12-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 the 12-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
Safety, tolerability and Patients related outcome
Not Provided
Not Provided
 
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
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.

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.

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
  • 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
  • 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
  • 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.
  • 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.
  • Placebo Comparator: Placebo
    Matching Placebo tablets administered twice a day
    Intervention: Other: Placebo
  • Experimental: Brivaracetam 20 mg/day
    Brivaracetam 20 mg/day, 10 mg administered twice a day
    Intervention: Drug: Brivaracetam
  • Experimental: Brivaracetam 50 mg/day
    Brivaracetam 50 mg/day, 25 mg administered twice a day
    Intervention: Drug: Brivaracetam
  • Experimental: Brivaracetam 100 mg/day
    Brivaracetam 100 mg/day, 50 mg administered twice a day
    Intervention: Drug: Brivaracetam
Ryvlin P, Werhahn KJ, Blaszczyk B, Johnson ME, Lu S. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):47-56. doi: 10.1111/epi.12432. Epub 2013 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
398
February 2009
February 2009   (final data collection date for primary outcome measure)

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 drugs (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
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Finland,   France,   Germany,   Hungary,   India,   Italy,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT00490035
N01252, 2006-006344-59
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
February 2013

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