A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:4 - 16
Updated:1/16/2019
Start Date:September 27, 2011
End Date:August 10, 2016

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A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter
study to evaluate the safety and efficacy of two dose levels of pregabalin administered in
equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive
therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.


Inclusion Criteria:

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

- Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the
Screening Visit.

- Diagnosis of epilepsy with partial onset seizures classified as simple partial,
complex partial or partial becoming secondarily generalized, according to the
International League Against Epilepsy (ILAE) Diagnosis criteria.

- Must have a partial onset seizure frequency of at least 3 seizures per 28 day period
prior to screening. Must have a partial onset seizure frequency of at least 6 seizures
and no continuous 4 week seizure free period during the 8 week baseline phase prior to
randomization.

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

Exclusion Criteria:

- Primary generalized seizures (including in the setting of co-existing partial onset
seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note
that partial onset seizures that become secondarily generalized are not exclusionary);
Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic
seizures.

- Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet
syndrome.

- A current diagnosis of febrile seizures, or seizures related to an ongoing acute
medical illness. Any febrile seizures within 1 year of screening.

- Status epilepticus within 1 year prior to screening.

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

- Any change in AED regimen (type of medication or dose) within 28 days of the Screening
Visit or during the Baseline Phase.

- Progressive structural CNS lesion or a progressive encephalopathy.
We found this trial at
22
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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Los Angeles, CA
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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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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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Durham, NC
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Durham, North Carolina 27710
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Lexington, KY
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Lexington, Kentucky 40536
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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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Little Rock, AR
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Los Angeles, California 90027
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Los Angeles, CA
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Louisville, Kentucky 40202
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Louisville, Kentucky 40202
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Loxahatchee Groves, Florida 33470
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Loxahatchee Groves, FL
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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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New Brunswick, NJ
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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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North Palm Beach, FL
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Ottignies,
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San Antonio, Texas 78258
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Tallahassee, Florida 32308
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