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Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures

NCT00437281•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.

Eligibility

Age

0 - 16 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Partial onset seizures, incompletely controlled on 1-3 medications
•At least 1 seizure per 28 days, on average

Exclusion Criteria

•Primary generalized seizures
•Progressive CNS pathology

Locations (18)

Pfizer Investigational Site

Mobile, Alabama, United States

Pfizer Investigational Site

Mobile, Alabama, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Jonesboro, Arkansas, United States

Pfizer Investigational Site

Little Rock, Arkansas, United States

Pfizer Investigational Site

San Francisco, California, United States

Pfizer Investigational Site

Gulf Breeze, Florida, United States

Pfizer Investigational Site

Pensacola, Florida, United States

Pfizer Investigational Site

Tampa, Florida, United States

Pfizer Investigational Site

Tampa, Florida, United States

Key Dates

Start Date

April 1, 2007

Primary Completion Date

November 1, 2012

Completion Date

November 1, 2012

Last Updated

February 11, 2021

Enrollment

ACTUAL participants

Conditions

Epilepsies, Partial

Interventions

Placebo

DRUG

Pregabalin

DRUG

Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies

NCT05015868

Epilepsies, PartialEpilepsy Intractable

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COMPLETED

Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study

NCT03054961

Epilepsies, Partial

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NOT_YET_RECRUITING

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: February 11, 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.

View ClinicalTrials.gov Terms and Conditions

Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

Inclusion Criteria

Exclusion Criteria

Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies

Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study

Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy

Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy

A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures