|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|
|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.|
|Masking: None (Open Label)|
Primary Purpose: Treatment
- Epilepsy, Partial Seizures
- Epilepsy, Primary Generalized Tonic-Clonic Seizures
Pregabalin administered as either capsule or liquid oral formulations. Subjects <4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ?4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.
Other Name: Lyrica
Pregabalin open label flexible dose
Intervention: Drug: Pregabalin
|August 22, 2019|
|August 22, 2019 (Final data collection date for primary outcome measure)|
- 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).
- 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.
|Sexes Eligible for Study:||All|
|1 Month to 66 Years (Child, Adult, Older Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Republic of, Lebanon, Malaysia, Montenegro, Philippines, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States|
|Argentina, Austria, Croatia, Czech Republic, Denmark, Estonia, Finland, Lithuania, Netherlands, South Africa|
2011-001412-65 ( EudraCT Number )
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|