A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
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
1 other identifier
interventional
210
4 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2005
Shorter than P25 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Start
First participant enrolled
November 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2006
CompletedResults Posted
Study results publicly available
August 22, 2018
CompletedOctober 2, 2018
September 1, 2018
8 months
September 9, 2005
October 26, 2017
September 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
Calculated as 7-day partial onset seizure frequency.
During the 7-week Treatment Period
Secondary Outcomes (10)
Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period
Baseline, during the 7-week Treatment Period
Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period
During the 7-week Treatment Period
Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period
During the 7-week Treatment Period
Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
During the 7-week Treatment Period
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
During the 7-week Treatment Period
- +5 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORMatching Placebo tablets administered twice a day
Brivaracetam 5 mg/day
EXPERIMENTALBrivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day
EXPERIMENTALBrivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day
EXPERIMENTALBrivaracetam 50 mg/day, 25 mg administered twice a day
Interventions
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (42)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
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Chicago, Illinois, United States
Unknown Facility
Paducah, Kentucky, United States
Unknown Facility
Ruston, Louisiana, United States
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Bethesda, Maryland, United States
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Burlington, Massachusetts, United States
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Grand Rapids, Michigan, United States
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Rochester, Minnesota, United States
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Tupelo, Mississippi, United States
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Chesterfield, Missouri, United States
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Great Falls, Montana, United States
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Englewood Cliffs, New Jersey, United States
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Toms River, New Jersey, United States
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New York, New York, United States
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Wilmington, North Carolina, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Woonsocket, Rhode Island, United States
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Greenville, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Florianópolis, Brazil
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Salvador, Brazil
Unknown Facility
São Paulo, Brazil
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Bangalore, India
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Hyderabad, India
Unknown Facility
Lucknow, India
Unknown Facility
Parel Mumbai, India
Unknown Facility
Trivandrum, India
Unknown Facility
Aguascalientes, Mexico
Unknown Facility
Chichuahua, Mexico
Unknown Facility
Chihuahua City, Mexico
Unknown Facility
Guadalajara, Mexico
Unknown Facility
Monterrey, Mexico
Unknown Facility
San Luis Potosí City, Mexico
Unknown Facility
Valle Oriente Garza Garcia, Mexico
Unknown Facility
Zapopan, Mexico
Related Publications (3)
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.
PMID: 27265725RESULTBresnahan 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.
PMID: 35285519DERIVEDBrandt 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.
PMID: 31937513DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
November 7, 2005
Primary Completion
June 29, 2006
Study Completion
June 29, 2006
Last Updated
October 2, 2018
Results First Posted
August 22, 2018
Record last verified: 2018-09