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

NCT ID: NCT00437281

Last Updated: 2021-02-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsies, Partial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Pregabalin

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

Orally-administered pregabalin

Interventions

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Placebo

Placebo

Intervention Type DRUG

Pregabalin

Orally-administered pregabalin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Mobile, Alabama, United States

Site Status

Pfizer Investigational Site

Mobile, Alabama, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Jonesboro, Arkansas, United States

Site Status

Pfizer Investigational Site

Little Rock, Arkansas, United States

Site Status

Pfizer Investigational Site

San Francisco, California, United States

Site Status

Pfizer Investigational Site

Gulf Breeze, Florida, United States

Site Status

Pfizer Investigational Site

Pensacola, Florida, United States

Site Status

Pfizer Investigational Site

Tampa, Florida, United States

Site Status

Pfizer Investigational Site

Tampa, Florida, United States

Site Status

Pfizer Investigational Site

Springfield, Missouri, United States

Site Status

Pfizer Investigational Site

Buffalo, New York, United States

Site Status

Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Guadalajara, Jalisco, Mexico

Site Status

Pfizer Investigational Site

Mexico City, Mexico City, Mexico

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Countries

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United States Mexico South Korea

References

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Mann D, Liu J, Chew ML, Bockbrader H, Alvey CW, Zegarac E, Pellock J, Pitman VW. Safety, tolerability, and pharmacokinetics of pregabalin in children with refractory partial seizures: a phase 1, randomized controlled study. Epilepsia. 2014 Dec;55(12):1934-43. doi: 10.1111/epi.12830. Epub 2014 Nov 6.

Reference Type DERIVED
PMID: 25377429 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081074&StudyName=Safety%2C%20Tolerability%2C%20and%20Pharmacokinetic%20Study%20of%20Pregabalin%20in%20Pediatric%20Patients%20with%20Partial%20Onset%20Seizures

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0081074

Identifier Type: -

Identifier Source: org_study_id

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