Epilepsy, Partial Seizures | 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
Epilepsy, Partial Seizures research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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 Criteria: - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Epilepsy, Partial Seizures
Epilepsy, Primary Generalized Tonic-Clonic Seizures
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PregabalinPregabalin 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
OpenPregabalin open label flexible dose
Start Date: February 21, 2012
Completed Date: July 8, 2020
Phase: Phase 3
Primary Outcome: SAE's (serious adverse event) and AE's (adverse events)
Secondary Outcome: Suicidality assessments
Study sponsors, principal investigator, and references
Principal Investigator: Pfizer CT.gov Call Center
Lead Sponsor: Pfizer