Back to resultsA Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Brivaracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy: partial onset seizures, brivaracetam
Eligibility Criteria
Inclusion Criteria: Male/female from 16 to 65 years Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification History of partial onset seizures Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1 Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose. Exclusion Criteria: Seizure type IA non-motor as only seizure type Seizures occurring only in clusters Status epilepticus during the last 2 years before Visit 1 History of cerebrovascular accident (CVA) Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Brivaracetam 5 mg/day
Brivaracetam 20 mg/day
Brivaracetam 50 mg/day
Arm Description
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Outcomes
Primary Outcome Measures
Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
Calculated as 7-day partial onset seizure frequency.
Secondary Outcome Measures
Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period
Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.
Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period
Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period
A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.
Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period
Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.
Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period
A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.
Number of Seizure-free Days Per 4 Weeks
A day was considered seizure-free, if no seizure was reported during 24 hours.
Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period
Number of days to first, fifth, and tenth seizure after baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00175825
Brief Title
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 7, 2005 (Actual)
Primary Completion Date
June 29, 2006 (Actual)
Study Completion Date
June 29, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy: partial onset seizures, brivaracetam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo tablets administered twice a day
Arm Title
Brivaracetam 5 mg/day
Arm Type
Experimental
Arm Description
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Arm Title
Brivaracetam 20 mg/day
Arm Type
Experimental
Arm Description
Brivaracetam 20 mg/day, 10 mg administered twice a day
Arm Title
Brivaracetam 50 mg/day
Arm Type
Experimental
Arm Description
Brivaracetam 50 mg/day, 25 mg administered twice a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
Briviact
Intervention Description
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Primary Outcome Measure Information:
Title
Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
Description
Calculated as 7-day partial onset seizure frequency.
Time Frame
During the 7-week Treatment Period
Secondary Outcome Measure Information:
Title
Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period
Description
Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame
Baseline, during the 7-week Treatment Period
Title
Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period
Description
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.
Time Frame
During the 7-week Treatment Period
Title
Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period
Description
Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame
During the 7-week Treatment Period
Title
Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Description
Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame
During the 7-week Treatment Period
Title
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Description
Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame
During the 7-week Treatment Period
Title
Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period
Description
A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.
Time Frame
During the 7-week Treatment Period
Title
Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period
Description
Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.
Time Frame
During the 7-week Treatment Period
Title
Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period
Description
A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.
Time Frame
During the 7-week Treatment Period
Title
Number of Seizure-free Days Per 4 Weeks
Description
A day was considered seizure-free, if no seizure was reported during 24 hours.
Time Frame
Baseline, during the 7-week Treatment Period
Title
Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period
Description
Number of days to first, fifth, and tenth seizure after baseline.
Time Frame
During the 7-week Treatment Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male/female from 16 to 65 years
Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
History of partial onset seizures
Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.
Exclusion Criteria:
Seizure type IA non-motor as only seizure type
Seizures occurring only in clusters
Status epilepticus during the last 2 years before Visit 1
History of cerebrovascular accident (CVA)
Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Fresno
State/Province
California
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United States
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Bradenton
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Florida
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United States
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Jacksonville
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Florida
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Chicago
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Illinois
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Paducah
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Kentucky
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Ruston
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Louisiana
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Bethesda
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Maryland
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Burlington
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Massachusetts
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Grand Rapids
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Michigan
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United States
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Rochester
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Minnesota
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Tupelo
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Mississippi
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United States
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Chesterfield
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Missouri
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Great Falls
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Montana
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Englewood Cliffs
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New Jersey
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United States
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Toms River
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New Jersey
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United States
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New York
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New York
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United States
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Wilmington
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North Carolina
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United States
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Columbus
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Ohio
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United States
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Philadelphia
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Pennsylvania
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United States
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Woonsocket
State/Province
Rhode Island
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United States
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Greenville
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South Carolina
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United States
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Dallas
State/Province
Texas
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United States
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Houston
State/Province
Texas
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United States
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Salt Lake City
State/Province
Utah
Country
United States
City
Florianopolis
Country
Brazil
City
Salvador
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Bangalore
Country
India
City
Hyderabad
Country
India
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Lucknow
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India
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Parel Mumbai
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India
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Trivandrum
Country
India
City
Aguascalientes
Country
Mexico
City
Chichuahua
Country
Mexico
City
Chihuahua
Country
Mexico
City
Guadalajara
Country
Mexico
City
Monterrey
Country
Mexico
City
San Luis Potosi
Country
Mexico
City
Valle Oriente Garza Garcia
Country
Mexico
City
Zapopan
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
27265725
Citation
Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.
Results Reference
result
PubMed Identifier
35285519
Citation
Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.
Results Reference
derived
PubMed Identifier
31937513
Citation
Brandt C, Klein P, Badalamenti V, Gasalla T, Whitesides J. Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. Epilepsy Behav. 2020 Feb;103(Pt A):106864. doi: 10.1016/j.yebeh.2019.106864. Epub 2020 Jan 12.
Results Reference
derived
Links:
URL
https://www.briviact.com/briviact-PI.pdf?v=1479491757
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
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