A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
NCT ID: NCT00175825
Last Updated: 2018-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
2005-11-07
2006-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching Placebo tablets administered twice a day
Placebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
Brivaracetam 5 mg/day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Brivaracetam 20 mg/day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Brivaracetam 50 mg/day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Interventions
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Placebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
65 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Fresno, California, United States
Bradenton, Florida, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
Paducah, Kentucky, United States
Ruston, Louisiana, United States
Bethesda, Maryland, United States
Burlington, Massachusetts, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
Tupelo, Mississippi, United States
Chesterfield, Missouri, United States
Great Falls, Montana, United States
Englewood Cliffs, New Jersey, United States
Toms River, New Jersey, United States
New York, New York, United States
Wilmington, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Woonsocket, Rhode Island, United States
Greenville, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Florianópolis, , Brazil
Salvador, , Brazil
São Paulo, , Brazil
Bangalore, , India
Hyderabad, , India
Lucknow, , India
Parel Mumbai, , India
Trivandrum, , India
Aguascalientes, , Mexico
Chichuahua, , Mexico
Chihuahua City, , Mexico
Guadalajara, , Mexico
Monterrey, , Mexico
San Luis Potosí City, , Mexico
Valle Oriente Garza Garcia, , Mexico
Zapopan, , Mexico
Countries
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References
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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.
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.
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.
Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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N01193
Identifier Type: -
Identifier Source: org_study_id
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