A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures
NCT ID: NCT00699283
Last Updated: 2018-07-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
62 participants
INTERVENTIONAL
2008-08-31
2010-03-31
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
TRIPLE
Study Groups
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Brivaracetam (BRV) 1
50 mg daily
Brivaracetam
25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)
Brivaracetam (BRV) 2
100 mg daily
Brivaracetam
25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
Interventions
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Brivaracetam
25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)
Brivaracetam
25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Well-characterized focal epilepsy or epileptic syndrome
* Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
* Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50% of the minimum recommended maintenance dose
Exclusion Criteria
* History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
* Other serious uncontrolled disease
16 Years
75 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Little Rock, Arkansas, United States
Garden Grove, California, United States
Loma Linda, California, United States
Newport Beach, California, United States
Riverside, California, United States
Sacramento, California, United States
Stanford, California, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Danbury, Connecticut, United States
New Haven, Connecticut, United States
Waterbury, Connecticut, United States
Gainesville, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Danville, Indiana, United States
Elkhart, Indiana, United States
Waldorf, Maryland, United States
Grand Rapids, Michigan, United States
Columbia, Missouri, United States
Lebanon, New Hampshire, United States
Albuquerque, New Mexico, United States
Flushing, New York, United States
Schenectady, New York, United States
Charlotte, North Carolina, United States
Oberlin, Ohio, United States
Westerville, Ohio, United States
Tulsa, Oklahoma, United States
Bethlehem, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Providence, Rhode Island, United States
Austin, Texas, United States
Bedford, Texas, United States
San Antonio, Texas, United States
Layton, Utah, United States
Ogden, Utah, United States
Burlington, Vermont, United States
Bluefield, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Marshfield, Wisconsin, United States
Béthune, , France
Lille, , France
Saint-Brieuc, , France
Toulouse, , France
Berlin, , Germany
Bernau, , Germany
Bielefeld, , Germany
München, , Germany
Münster, , Germany
Ulm, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Kecskemét, , Hungary
Szeged, , Hungary
Bergamo, , Italy
Florence, , Italy
Germaneto, , Italy
Messina, , Italy
Perugia, , Italy
Pisa, , Italy
Torino, , Italy
Barcelona, , Spain
Madrid, , Spain
Murcia, , Spain
Zaragoza, , Spain
Countries
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References
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Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.
Other Identifiers
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RPCE07F1216
Identifier Type: -
Identifier Source: secondary_id
2008-000145-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01306
Identifier Type: -
Identifier Source: org_study_id
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