Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
NCT ID: NCT00524030
Last Updated: 2021-01-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
161 participants
INTERVENTIONAL
2007-09-30
2011-06-30
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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1
pregabalin 600 mg/day
pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
2
pregabalin 150 mg/day
pregabalin 150 mg/day (75mg BID), duration is 20 weeks.
Interventions
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pregabalin 600 mg/day
pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
pregabalin 150 mg/day
pregabalin 150 mg/day (75mg BID), duration is 20 weeks.
Eligibility Criteria
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Inclusion Criteria
* Males or females, age 18 years or older.
* Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
* Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.
Exclusion Criteria
* Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
* Primary generalized epilepsy or status epilepticus within the previous year.
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
Northport, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
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Sun City, Arizona, United States
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Fayetteville, Arkansas, United States
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Fullerton, California, United States
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Long Beach, California, United States
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Modesto, California, United States
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Murrieta, California, United States
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Newport Beach, California, United States
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Temecula, California, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Sarasota, Florida, United States
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Sarasota, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Lawrenceville, Georgia, United States
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Suwanee, Georgia, United States
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Anderson, Indiana, United States
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Danville, Indiana, United States
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Fort Wayne, Indiana, United States
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Kansas City, Kansas, United States
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Bowling Green, Kentucky, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Houma, Louisiana, United States
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Shreveport, Louisiana, United States
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Pikesville, Maryland, United States
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Worcester, Massachusetts, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
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Detroit, Michigan, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Flowood, Mississippi, United States
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Hattiesburg, Mississippi, United States
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Great Falls, Montana, United States
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Cedarhurst, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Indiana, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Murray, Utah, United States
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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Milwaukee, Wisconsin, United States
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Beroun, , Czechia
Pfizer Investigational Site
Brno, , Czechia
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Litomyšl, , Czechia
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New Territories, , Hong Kong
Pfizer Investigational Site
Dnipropetrovsk, , Ukraine
Pfizer Investigational Site
Dnipropetrovsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
Pfizer Investigational Site
Luhansk, , Ukraine
Pfizer Investigational Site
Odesa, , Ukraine
Countries
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References
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French J, Kwan P, Fakhoury T, Pitman V, DuBrava S, Knapp L, Yurkewicz L. Pregabalin monotherapy in patients with partial-onset seizures: a historical-controlled trial. Neurology. 2014 Feb 18;82(7):590-7. doi: 10.1212/WNL.0000000000000119. Epub 2014 Jan 10.
Other Identifiers
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A0081047
Identifier Type: -
Identifier Source: org_study_id
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