Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures - Full Text View

Purpose

This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.

Condition	Intervention	Phase
Epilepsy	Drug: Placebo Drug: Brivaracetam Drug: Antiepileptic drugs with market authorization available per country	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:	A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 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

Drug Information available for: Brivaracetam

U.S. FDA Resources

Further study details as provided by UCB Pharma:

Primary Outcome Measures:

Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
Primary endpoint: United States of America (FDA)
50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration [ Time Frame: Baseline to 12 week Treatment Period ] [ Designated as safety issue: No ]
Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.

Secondary Outcome Measures:

Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period [ Time Frame: Baseline to 12 week Treatment Period ] [ Designated as safety issue: No ]
Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period [ Time Frame: Baseline to 12 week Treatment Period ] [ Designated as safety issue: No ]
Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
Time to the First Type I Seizure During the Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
Time to the Fifth Type I Seizure During the Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
Time to the Tenth Type I Seizure During the Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]


Enrollment:	768
Study Start Date:	December 2010
Study Completion Date:	May 2014
Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Matching placebo tablets administered twice daily	Drug: Placebo Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period Drug: Antiepileptic drugs with market authorization available per country
Experimental: Brivaracetam 100 mg/ day Brivaracetam 50 mg/ day administered twice daily.	Drug: Brivaracetam Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period Drug: Antiepileptic drugs with market authorization available per country
Experimental: Brivaracetam 200 mg/ day Brivaracetam 100 mg/ day administered twice daily	Drug: Brivaracetam Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period. Drug: Antiepileptic drugs with market authorization available per country

Eligibility


Ages Eligible for Study:	16 Years to 80 Years (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years
Subjects having at least 8 Type I seizures [POS; focal seizures (according to the 1981 ILAE classification)] during the 8-week Baseline Period with at least 2 Type I seizures during each 4-week interval of the Baseline Period
Subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1
Subjects being uncontrolled while treated by 1 or 2 permitted concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital, phenytoin, and primidone) before V1 and expected to be kept stable during the Baseline and Treatment Period. Benzodiazepine taken more than once a week (for any indication) will be considered as a concomitant AED

Exclusion Criteria:

Subject previously randomized within this study or any other prior study with BRV as a dosing arm
Seizure type IA (1981 ILAE classification) nonmotor as only seizure type.
Subject is currently treated with LEV or has taken LEV within 90 days prior to V1
Subject has any medical or psychiatric condition, obvious cognitive impairment or mental retardation that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
Subject has history or presence of status epilepticus during the year preceding V1 or during Baseline
Subject has history or presence of known psychogenic nonepileptic seizures
Subject on felbamate with less than 18 months exposure before V1
Subject currently on vigabatrin. Subject with history of vigabatrin use but either no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or results of these examinations are abnormal
Subject taking any drug with possible central nervous system (CNS) effects except if stable from at least 1 month before V1 and expected to be kept stable during the Treatment Period
Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 6 months
Subject is suffering from severe cardiovascular disease or peripheral vascular disease
Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
Subject has ongoing psychiatric disease other than mild controlled disorder

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: NCT01261325

Show 208 Study Locations

Sponsors and Collaborators

UCB Pharma

Investigators


Study Director:	UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.

Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.


Responsible Party:	UCB Pharma
ClinicalTrials.gov Identifier:	NCT01261325 History of Changes
Other Study ID Numbers:	N01358 2010-019361-28
Study First Received:	December 9, 2010
Results First Received:	March 14, 2016
Last Updated:	July 4, 2016
Health Authority:	Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicines and Health Products, FAMHP Brazil: National Health Surveillance Agency Canada: Health Canada Mexico: Federal Commission for Protection Against Health Risks China: Food and Drug Administration Czech Republic: State Institute for Drug Control Estonia: The State Agency of Medicine Finland: Ministry of Social Affairs and Health France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Hong Kong: Department of Health Hungary: National Institute of Pharmacy India: Central Drugs Standard Control Organization Italy: Ministry of Health Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: Ministry of Health, Welfare and Sport Poland: Ministry of Health Russia: Pharmacological Committee, Ministry of Health South Korea: Korea Food and Drug Administration (KFDA) Spain: Ministry of Health and Consumption Sweden: The National Board of Health and Welfare Taiwan : Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by UCB Pharma:


Epilepsy Brivaracetam Partial Onset Seizures Adjunctive treatment

Additional relevant MeSH terms:


Epilepsy Seizures Brain Diseases Central Nervous System Diseases	Nervous System Diseases Neurologic Manifestations Signs and Symptoms Anticonvulsants

ClinicalTrials.gov processed this record on September 28, 2016

Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures (BRITE)