Status:
COMPLETED
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
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Epilepsy, Partial Seizures
Epilepsy, Primary Generalized Tonic-Clonic Seizures
Eligibility:
All Genders
1-66 years
Phase:
PHASE3
Brief Summary
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 seiz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2019
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT01463306
Start Date
February 21 2012
End Date
August 22 2019
Last Update
January 20 2021
Active Locations (151)
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1
Center for Neurosciences
Tucson, Arizona, United States, 85718
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
4
Axcess Medical Research
Loxahatchee Groves, Florida, United States, 33470