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

Phase 3CompletedNCT02072824

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.175 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

175

Conditions

Partial Onset Seizures

Interventions

Pregabalin Dose Level 1DRUG

Pregabalin Dose Level 2DRUG

Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase

Eligibility

Sex: ALLMin age: 1 MonthMax age: 3 Years

Medical Language ↔ Plain English

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.

Locations (72)

Pediatric Epilepsy Center of Central Florida

Orlando, Florida, United States

Pediatric Neurology, PA

Orlando, Florida, United States

Pediatric Epilepsy & Neurology Specialists, PA

Tampa, Florida, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Road Runner Research, Ltd.

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase

All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).

Time frame: Day 1 up to Day 14

Secondary Outcomes

Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase

Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment.

Time frame: Day 1 up to Day 14