A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any - 65
Updated:3/27/2019
Start Date:February 21, 2012
End Date:February 29, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

Study A0081106 is a 12-month open-label study to evaluate the long term safety and
tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age
with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with
primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided
daily doses for 1 year, in either capsule or liquid oral formulation.


Inclusion Criteria:

- Subjects and/or parent(s)/legally acceptable representative must be considered willing
and able to sign consent, and complete daily dosing and seizure diaries and complete
all scheduled visits.

- Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of
the Screening Visit.

- Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or
partial becoming secondarily generalized, or primary generalized tonic-clonic seizures
according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria.

- Partial onset seizure subjects must have had an average of at least 3 seizures per 28
day period in the 3 months prior to screening.

- Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days
prior to screening).

Exclusion Criteria:

- Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy
with Centrotemporal Spikes), and Dravet syndrome,

- A current diagnosis of febrile seizures or any febrile seizure within 1 year of
screening.

- Status epilepticus within 1 year prior to visit 1.

- Seizures related to drugs, alcohol, or acute medical illness.

- Progressive structural CNS lesion or a progressive encephalopathy.
We found this trial at
23
sites
1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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231 E Chestnut St
Louisville, Kentucky 40202
(502) 629-6000
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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Louisville, KY
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7485 Sandlake Commons Blvd.
Orlando, Florida 32835
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Orlando, FL
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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Canton, OH
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Honolulu, Hawaii 96817
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Indianapolis, Indiana 46256
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Louisville, Kentucky 40202
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Loxahatchee Groves, Florida 33470
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Minsk,
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254 Easton Ave
New Brunswick, New Jersey 08901
(732) 745-8600
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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North Palm Beach, Florida 33408
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Orlando, FL
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Renton, Washington 98057
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San Antonio, Texas 78258
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Tallahassee, Florida 32308
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