A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

• Status: Completed
• Trial end date: 2018-03-13
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Subject must have 3 partial onset seizures in the month prior to screening.

• Subject must have 2 partial onset seizures during the 48 hour baseline phase.

• Signed Informed Consent.

• On 1-3 stable anti-epileptic drugs at screening.

Exclusion Criteria:

• Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.

• Lennox-Gasteau, BECTS, and Dravet's syndrome.

• Status epliepticus within 1 year of screening.

• Any change in AED regimen with 7 days of screening.

• Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.

• Progressive errors of metabolism.