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
  Purpose

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.


Condition Intervention Phase
Epilepsies, Partial
Drug: Placebo
Drug: Pregabalin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 65
Study Start Date: April 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo
Experimental: Pregabalin Drug: Pregabalin
Orally-administered pregabalin

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437281

Locations
United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36693
Pfizer Investigational Site
Mobile, Alabama, United States, 36604
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
United States, Arkansas
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94143
United States, Florida
Pfizer Investigational Site
Gulf Breeze, Florida, United States, 32561
Pfizer Investigational Site
Pensacola, Florida, United States, 32504
Pfizer Investigational Site
Tampa, Florida, United States, 33603
Pfizer Investigational Site
Tampa, Florida, United States, 33609
United States, Missouri
Pfizer Investigational Site
Springfield, Missouri, United States, 65804
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14222
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
San Antonio, Texas, United States, 78258
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 06720
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44280
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00437281     History of Changes
Other Study ID Numbers: A0081074
Study First Received: February 16, 2007
Last Updated: December 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Partial-onset seizures; epilepsy; pediatric; pregabalin; safety; tolerability; pharmacokinetics

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013