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

Completed · Phase 3 · Has a placebo group

Conditions studied: Epilepsy, Partial Seizures

In brief

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.

Key facts

Study ID

NCT01389596

Run by

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

People needed

295

Starts

2011-09-27

Expected to finish

2016-08-10

Last updated by the study team

2021-01-20

Who can join

Age: 4 and older, up to 16. 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 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).

You may not qualify if…

• 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.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Los Angeles — Los Angeles, California, 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 Neurology, P.A. — Orlando, Florida, United States
• Tallahassee Neurological Clinic — Tallahassee, Florida, United States
• Center for Clinical and Translational Science — Lexington, Kentucky, United States
• Kentucky Neuroscience Institute — Lexington, Kentucky, United States
• University of Kentucky Hospital Epilepsy Monitoring Unit — Lexington, Kentucky, United States
• University of Kentucky Hospital Pharmacy, UK Chandler Hosptial — Lexington, Kentucky, United States
• Kosair Charities Pediatric Clinical — Louisville, Kentucky, 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
• Duke Children's Hospital and Health Center — Durham, North Carolina, United States
• Duke Clinical Research Unit — Durham, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Road Runner Research, Ltd. — San Antonio, Texas, United States
• Centre Hospitalier Neurologique William Lennox — Ottignies, Brabant Wallon, Belgium
• HUDERF — Brussels, Brussels Capital, Belgium
• Cliniques Universitaires de Bruxelles Hôpital Erasme — Brussels, Belgium
• UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania — Plovdiv, Bulgaria
• Fakultni nemocnice Brno - Detska nemocnice — Brno - Cerna Pole, Czechia
• Center for Neurosciences — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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