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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00437281

First received: February 16, 2007

Last updated: December 7, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 16, 2007

Last Updated Date

December 7, 2012

Start Date ^ICMJE

April 2007

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency and severity of adverse events; physical and neurologic exams;vital signs; ECGs; laboratory tests; seizure frequency throughout the 8 day study period. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Frequency and severity of adverse events; physical and neurologic exams; vital signs; ECGs; laboratory tests; seizure frequency throughout the 8 day study period.

Change History

Complete list of historical versions of study NCT00437281 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetic endpoints (Cmax, Tmax, AUC, Clearance, T 1/2) at Day 8. [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Pharmacokinetic endpoints (Cmax, Tmax, AUC, Clearance, T 1/2) at Day 8.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsies, Partial

Intervention ^ICMJE

Drug: Placebo
Placebo
Drug: Pregabalin
Orally-administered pregabalin

Study Arm (s)

Placebo Comparator: Placebo
Intervention: Drug: Placebo
Experimental: Pregabalin
Intervention: Drug: Pregabalin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Month to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Korea, Republic of, Mexico

Administrative Information

NCT Number ^ICMJE

NCT00437281

Other Study ID Numbers ^ICMJE

A0081074

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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