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

Completed · Phase 3

Conditions studied: Epilepsy, Partial Seizures, Epilepsy, Primary Generalized Tonic-Clonic Seizures

In brief

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.

Key facts

Study ID

NCT01463306

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

605

Starts

2012-02-21

Expected to finish

2019-08-22

Last updated by the study team

2021-01-20

Who can join

Age: 0 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Axcess Medical Research — Loxahatchee Groves, Florida, United States
• Laszlo J. Mate, M.D., P.A. — North Palm Beach, Florida, United States
• Pediatric Epilepsy Center Of Central Florida — Orlando, Florida, United States
• Pediatric Neurology, PA — Orlando, Florida, United States
• Tallahassee Neurological Clinic — Tallahassee, Florida, United States
• Pediatric Epilepsy and Neurology Specialists, PA — Tampa, Florida, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Josephson Wallack Munshower Neurology P.C. — Indianapolis, Indiana, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• University of Louisville Physicians — Louisville, Kentucky, United States
• Saint Peter's University Hospital — New Brunswick, New Jersey, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Ohio Clinical Research Partners, LLC — Canton, Ohio, United States
• The children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Dallas Pediatric Neurology Associates — Dallas, Texas, United States
• Road Runner Research, Ltd. — San Antonio, Texas, United States
• Rainier Clinical Research Center, Inc. — Renton, Washington, United States
• GU Republican Scientific and Practical Center Mother and Child — Minsk, Belarus
• UZ Vitebsk Regional Childrens Clinical Centre — Vitebsk, Belarus
• UZ Vitebsk Regional Childrens Clinical Centre — Vitebsk, Belarus
• Hopital Universitaire Des Enfants Reine Fabiola — Brussels, Brussels Capital, Belgium
• Center for Neurosciences — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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