Conversion to Monotherapy Study With Keppra XR for Partial Seizures
NCT ID: NCT00419094
Last Updated: 2014-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
228 participants
INTERVENTIONAL
2007-08-31
2009-09-30
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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Keppra XR 1000 mg/day
1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)
Keppra XR
Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
Keppra XR 2000 mg/day
2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)
Keppra XR
Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks
Interventions
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Keppra XR
Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
Keppra XR
Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks
Eligibility Criteria
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Inclusion Criteria
* Subjects must have inadequately controlled partial onset epilepsy.
* Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)
Exclusion Criteria
* Significant medical, psychiatric or neurological illness.
* Intake of benzodiazepines on more than an occasional basis
* History of previous treatment with levetiracetam or sensitivity to levetiracetam.
12 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
Locations
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Dothan, Alabama, United States
Northport, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Jacksonville, Florida, United States
Loxahatchee Groves, Florida, United States
Atlanta, Georgia, United States
Suwanee, Georgia, United States
Winfield, Illinois, United States
Witchita, Kansas, United States
Shreveport, Louisiana, United States
Bethesda, Maryland, United States
Detroit, Michigan, United States
Camden, New Jersey, United States
New Brunswick, New Jersey, United States
Buffalo, New York, United States
Cedarhurst, New York, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Bend, Oregon, United States
Monaca, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Beaufort, South Carolina, United States
Monterrey, Nuevo León, Mexico
Aguascalientes, , Mexico
Distrio Federal, , Mexico
Guadalajara, , Mexico
Guadalajara Jalisco, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Bialystok, , Poland
Gdansk, , Poland
Katowice, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Szczecin, , Poland
Warsaw, , Poland
Kalingrad, , Russia
Kazan', , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Yaroslavl, , Russia
Countries
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References
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Chung S, Ceja H, Gawlowicz J, Avakyan G, McShea C, Schiemann J, Lu S. Levetiracetam extended release conversion to monotherapy for the treatment of patients with partial-onset seizures: a double-blind, randomised, multicentre, historical control study. Epilepsy Res. 2012 Aug;101(1-2):92-102. doi: 10.1016/j.eplepsyres.2012.03.007. Epub 2012 Apr 18.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2007-000897-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01280
Identifier Type: -
Identifier Source: org_study_id
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