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

Viatris

Status and phase

Completed

Phase 3

Conditions

Epilepsy, Primary Generalized Tonic-Clonic Seizures

Epilepsy, Partial Seizures

Treatments

Drug: Pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01463306

2011-001412-65 (EudraCT Number)

A0081106

Details and patient eligibility

About

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.

Enrollment

605 patients

Sex

All

Ages

1 month to 66 years old

Volunteers

No Healthy Volunteers

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.