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

COMPLETEDPHASE3

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

A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures

NCT02072824•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 3 years

Sex

ALL

Healthy Volunteers

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

GU Republican Scientific and Practical Center Mother and Child

Minsk, Belarus

UZ Brussel

Brussels, Brussels Capital, 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

Key Dates

Start Date

September 16, 2014

Primary Completion Date

March 13, 2018

Completion Date

March 13, 2018

Last Updated

January 20, 2021

Enrollment

175

ACTUAL participants

Conditions

Partial Onset Seizures

Interventions

Pregabalin Dose Level 1

DRUG

Pregabalin Dose Level 2

DRUG

Placebo

DRUG

A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

NCT01710657

EpilepsyPartial Onset Seizures

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COMPLETEDPHASE2/PHASE3

Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

NCT00975715

Partial Onset Seizures

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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