Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures



Status:Terminated
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:September 2007
End Date:June 2011

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A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by
itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment
of partial seizures. The duration of the trial is about 6 months.

After review of the interim analysis results, the independent Data Monitoring Committee (DMC)
recommended to stop the study based on positive efficacy findings for the primary efficacy
endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation
and made the decision to stop the study on September 7, 2011.

Inclusion Criteria:

- Diagnosis of epilepsy with partial seizures.

- 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:

- Current diagnosis of febrile seizures or seizures related to an ongoing acute medical
event.

- 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.
We found this trial at
54
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Modesto, California 95355
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Altoona, Pennsylvania 16601
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Anderson, Indiana 46016
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Anderson, IN
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Atlanta, Georgia 30309
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Bowling Green, Kentucky 42101
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Cedarhurst, New York 11516
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Charlotte, North Carolina 28277
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Cleveland, Ohio 44195
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Columbus, Ohio 43210
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Dallas, Texas 75204
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Danville, Indiana 46122
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Decatur, Georgia 30033
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Denver, Colorado 80206
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Detroit, Michigan 48202
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Fayetteville, Arkansas 72703
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Flowood, Mississippi 39232
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Fort Wayne, Indiana 46805
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Fullerton, California 92835
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Great Falls, Montana 59405
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Hattiesburg, Mississippi 39401
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Houma, Louisiana 70363
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Houston, Texas 77030
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Indiana, Pennsylvania 15701
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Indiana, PA
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Jacksonville, Florida 32216
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Kansas City, Kansas 66104
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Lawrenceville, Georgia 30045
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Lexington, Kentucky 40504
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Long Beach, California 90806
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Melbourne, Florida 32901
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Memphis, Tennessee 38103
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Miami, Florida 33155
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Milwaukee, Wisconsin 53226
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Minneapolis, Minnesota 55422
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Murray, Utah 84107
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Murrieta, California 92563
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Nashville, Tennessee 37203
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Newport Beach, California 92663
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Northport, Alabama 35476
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Oklahoma City, Oklahoma 73112
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Philadelphia, Pennsylvania 19134
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Phoenix, Arizona 85016
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Pikesville, Maryland 21208
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Rocky Mount, North Carolina 27804
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Salt Lake City, Utah 84103
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San Antonio, Texas 78258
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Sarasota, Florida 34239
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Shreveport, Louisiana 71115
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Sun City, Arizona 85372
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Suwanee, Georgia 30024
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Temecula, California 92591
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Temple, Texas 76508
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West Jordan, Utah 84088
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Worcester, Massachusetts 01605
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