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: NCT00698581
Last Updated: 2018-07-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
88 participants
INTERVENTIONAL
2008-08-31
2010-02-28
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 50 mg
50 mg/day
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 100 mg
100 mg/day
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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Phoenix, Arizona, United States
Fresno, California, United States
Pasadena, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Orlando, Florida, United States
Conyers, Georgia, United States
Macon, Georgia, United States
Peoria, Illinois, United States
Lexington, Kentucky, United States
Burlington, Massachusetts, United States
Las Vegas, Nevada, United States
Summit, New Jersey, United States
Mineola, New York, United States
New York, New York, United States
The Bronx, New York, United States
Hickory, North Carolina, United States
Kettering, Ohio, United States
Oklahoma City, Oklahoma, United States
Germantown, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Danville, Virginia, United States
Charleston, West Virginia, United States
Waukesha, Wisconsin, United States
Chatswood, New South Wales, Australia
Adelaide, South Australia, Australia
Clayton, Victoria, Australia
Fitzroy, Victoria, Australia
Parkville, Victoria, Australia
West Heidelberg, Victoria, Australia
Ghent, , Belgium
Kortrijk, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Sakaskatoon, Saskatchewan, Canada
Brno, , Czechia
Litomyšl, , Czechia
Ostava, , Czechia
Ostrava-Trebovice, , Czechia
Prague, , Czechia
Praha-4, , Czechia
Aschaffenburg, , Germany
Halle, , Germany
Mainz, , Germany
Regensburg, , Germany
Gothenburg, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
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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2008-000144-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01276
Identifier Type: -
Identifier Source: org_study_id
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