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

Phase 3

Completed

Interventions: Drug: Pregabalin Dose Level 1
Drug: Pregabalin Dose Level 2
Drug: Placebo

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase	Day 1 up to Day 14	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).

Secondary Outcome Measures

Name	Time	Method
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	Day 1 up to Day 14	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.

Locations (68): 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
GU Republican Scientific and Practical Center Mother and Child
🇧🇾
Minsk, Belarus
UZ Brussel
🇧🇪
Brussels, Bruxelles Capitale, Belgium
University Clinical Centre of the Republic of Srpska
🇧🇦
Banja Luka, Bosnia and Herzegovina
UMHAT Dr. Georgi Stranski Ltd.
🇧🇬
Pleven, Bulgaria
UMHAT "Sveti Georgi" Ltd.
🇧🇬
Plovdiv, Bulgaria
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Pediatric Epilepsy Center of Central Florida
🇺🇸Orlando, Florida, United States