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

Tracking Information

First Received Date ^ICMJE

February 16, 2007

Last Updated Date

November 19, 2009

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

December 2009 (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.

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

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study

Condition ^ICMJE

Epilepsies, Partial

Intervention ^ICMJE

Drug: Placebo
Drug: Pregabalin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (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: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00437281

Responsible Party

Director, Clinical Trials Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A0081074

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2009

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