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Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
This study is currently recruiting participants.
Study NCT00437281   Information provided by Pfizer
First Received: February 16, 2007   Last Updated: November 19, 2009   History of Changes

February 16, 2007
November 19, 2009
March 2007
December 2009   (final data collection date for primary outcome measure)
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 ]
Frequency and severity of adverse events; physical and neurologic exams; vital signs; ECGs; laboratory tests; seizure frequency throughout the 8 day study period.
Complete list of historical versions of study NCT00437281 on ClinicalTrials.gov Archive Site
Pharmacokinetic endpoints (Cmax, Tmax, AUC, Clearance, T 1/2) at Day 8. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Pharmacokinetic endpoints (Cmax, Tmax, AUC, Clearance, T 1/2) at Day 8.
 
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

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.

 
Phase I, Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Epilepsies, Partial
  • Drug: Placebo
  • Drug: Pregabalin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
1 Month to 16 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States
 
NCT00437281
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
A0081074
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2009

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