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

Purpose

This 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 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, 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

MedlinePlus related topics: Epilepsy Seizures

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 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: Basline 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 Treatnment 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:	400
Study Start Date:	September 2007
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (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 5 mg/day Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Drug: Brivaracetam Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg /day in a double-blinded way for the 12-week Treatment period
Experimental: BRV 20mg/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: BRV 50mg/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

Eligibility

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

Criteria

Inclusion Criteria:

Subjects were 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 (V1).
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(s) (AEDs). Vagal nerve stimulation (VNS) 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: NCT00464269

Show 70 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:	NCT00464269 History of Changes
Other Study ID Numbers:	N01253
Study First Received:	April 19, 2007
Last Updated:	August 13, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Brazil: National Health Surveillance Agency Mexico: Federal Commission for Protection Against Health Risks Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by UCB, Inc.:

Epilepsy
Brivaracetam
Partial Onset Seizures, Adolescents & Adults

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 May 23, 2013