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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Age
0–66
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | 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
