Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
509 participants
INTERVENTIONAL
2007-10-31
2012-05-31
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
TRIPLE
Study Groups
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B
pregabalin
300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
A
levetiracetam
1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
Interventions
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pregabalin
300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
levetiracetam
1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
Eligibility Criteria
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Inclusion Criteria
* Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
* Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.
Exclusion Criteria
* Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Duffel, , Belgium
Pfizer Investigational Site
Yvoir, , Belgium
Pfizer Investigational Site
Kyustendil, , Bulgaria
Pfizer Investigational Site
Pernik, , Bulgaria
Pfizer Investigational Site
Plovdiv, , Bulgaria
Pfizer Investigational Site
Rousse, , Bulgaria
Pfizer Investigational Site
Sofia, , Bulgaria
Pfizer Investigational Site
Sofia, , Bulgaria
Pfizer Investigational Site
Barranquilla, Atlántico, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Montes de Oca, Provincia de San José, Costa Rica
Pfizer Investigational Site
San José, , Costa Rica
Pfizer Investigational Site
Brno, , Czechia
Pfizer Investigational Site
Hradec Králové, , Czechia
Pfizer Investigational Site
Olomouc, , Czechia
Pfizer Investigational Site
Ostrava-Trebovice, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Příbram, , Czechia
Pfizer Investigational Site
Rychnov nad Kněžnou, , Czechia
Pfizer Investigational Site
Strasbourg, , France
Pfizer Investigational Site
Toulouse, , France
Pfizer Investigational Site
Bonn, , Germany
Pfizer Investigational Site
Hamburg, , Germany
Pfizer Investigational Site
Athens, , Greece
Pfizer Investigational Site
Thessaloniki, , Greece
Pfizer Investigational Site
Pune, Maharashtra, India
Pfizer Investigational Site
Chandigarh, Punjab, India
Pfizer Investigational Site
Ludhiana, Punjab, India
Pfizer Investigational Site
Florence, , Italy
Pfizer Investigational Site
Foggia, , Italy
Pfizer Investigational Site
Pisa, , Italy
Pfizer Investigational Site
Siena, , Italy
Pfizer Investigational Site
Kaunas, , Lithuania
Pfizer Investigational Site
Vilnius, , Lithuania
Pfizer Investigational Site
Distrito Federal, , Mexico
Pfizer Investigational Site
San Luis Potosí City, , Mexico
Pfizer Investigational Site
Panama City, , Panama
Pfizer Investigational Site
Lima, , Peru
Pfizer Investigational Site
Lima, , Peru
Pfizer Investigational Site
Tondo, Manila, Philippines
Pfizer Investigational Site
Cebu City, , Philippines
Pfizer Investigational Site
Davao City, , Philippines
Pfizer Investigational Site
Makati City, , Philippines
Pfizer Investigational Site
Manila, , Philippines
Pfizer Investigational Site
Quezon City, , Philippines
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Busan, , South Korea
Pfizer Investigational Site
Daejeon, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Donostia / San Sebastian, Guipuzcoa, Spain
Pfizer Investigational Site
Alicante, , Spain
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Córdoba, , Spain
Pfizer Investigational Site
Girona, , Spain
Pfizer Investigational Site
Seville, , Spain
Pfizer Investigational Site
Kaohsiung City, , Taiwan
Pfizer Investigational Site
Taichung, , Taiwan
Pfizer Investigational Site
Tainan City, , Taiwan
Pfizer Investigational Site
Çapa, Istanbul, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, , Turkey (Türkiye)
Pfizer Investigational Site
Cerrahpasa / Istanbul, , Turkey (Türkiye)
Pfizer Investigational Site
Caracas, Libertador, Venezuela
Pfizer Investigational Site
Caracas, Miranda, Venezuela
Countries
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References
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Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.
Other Identifiers
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A0081157
Identifier Type: -
Identifier Source: org_study_id
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