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
Condition: Epilepsy, Partial Seizures; Epilepsy, Primary Generalized Tonic-Clonic Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Pregabalin
Intervention description: 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.
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 605.0
Sex: All
Minimum age: 1 Month
Maximum age: 66 Years
Healthy volunteers: No
Keywords: safety; partial onset seizures; primary generalized tonic-clonic seizures; pregabalin; pediatric; adult; open-label; long term

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 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.
    

Eligibility criteria:

        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.