A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
NCT ID: NCT00368069
Last Updated: 2020-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
158 participants
INTERVENTIONAL
2006-08-31
2007-05-31
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
QUADRUPLE
Study Groups
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Keppra® XR
Keppra® extended release formulation -XR
Keppra® extended release formulation - XR
500mg extended release oral tablet, 2 tablets once daily
Placebo
placebo
Placebo
oral tablets, 2 tablets once daily
Interventions
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Keppra® extended release formulation - XR
500mg extended release oral tablet, 2 tablets once daily
Placebo
oral tablets, 2 tablets once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
* Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
Exclusion Criteria
* Status epilepticus within 3 months of Visit 1
* History of non-epileptic seizures
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
* Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control
12 Years
70 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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N01235 1007
Curitiba, , Brazil
N01235 2001
Kuopio, , Finland
N01235 2003
Tampere, , Finland
N01235 2002
Turku, , Finland
N01235 3008
Chennai, , India
N01235 3010
Chennai, , India
N01235 3012
Gandhinagar, , India
N01235 3003
Hyderabad, , India
N01235 3004
Hyderabad, , India
N01235 3001
Lucknow, , India
N01235 3009
Madurai, , India
N01235 3002
Mumbai, , India
N01235 3007
Mumbai, , India
N01235 3011
Visakhapatnam, , India
N01235 4006
Aguascalientes, , Mexico
N01235 4003
Distrio Federal, , Mexico
N01235 4001
Guadalajara, , Mexico
N01235 4005
Puebla City, , Mexico
N01235 5001
Moscow, , Russia
N01235 5002
Moscow, , Russia
N01235 5003
Moscow, , Russia
N01235 5005
Moscow, , Russia
N01235 5006
Moscow, , Russia
N01235 5007
Moscow, , Russia
N01235 5004
Saint Petersburg, , Russia
N01235 5009
Saint Petersburg, , Russia
N01235 5008
Smolensk, , Russia
N01235 6002
Cape Town, , South Africa
N01235 6003
Umhlanga, , South Africa
N01235 7001
Kharkiv, , Ukraine
N01235 7004
Kharkiv, , Ukraine
N01235 7005
Lviv, , Ukraine
N01235 7002
Odesa, , Ukraine
N01235 7003
Poltava, , Ukraine
Countries
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References
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Peltola J, Coetzee C, Jimenez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14. doi: 10.1111/j.1528-1167.2008.01817.x.
Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. doi: 10.1016/j.yebeh.2009.07.013. Epub 2009 Aug 20.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2006-000987-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01235
Identifier Type: -
Identifier Source: org_study_id
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