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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00437281

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 I Phase II

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:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Pregabalin

U.S. FDA Resources

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 ]

Estimated Enrollment:	80
Study Start Date:	April 2007
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, Alabama
Pfizer Investigational Site	Completed
Mobile, Alabama, United States, 36693
Pfizer Investigational Site	Completed
Mobile, Alabama, United States, 36604
United States, Arizona
Pfizer Investigational Site	Recruiting
Phoenix, Arizona, United States, 85016
United States, Arkansas
Pfizer Investigational Site	Terminated
Jonesboro, Arkansas, United States, 72401
Pfizer Investigational Site	Terminated
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site	Recruiting
Los Angeles, California, United States, 90095
Pfizer Investigational Site	Recruiting
San Francisco, California, United States, 94143
United States, Florida
Pfizer Investigational Site	Completed
Gulf Breeze, Florida, United States, 32561
Pfizer Investigational Site	Completed
Pensacola, Florida, United States, 32504
Pfizer Investigational Site	Recruiting
Tampa, Florida, United States, 33609
Pfizer Investigational Site	Recruiting
Tampa, Florida, United States, 33603
United States, Missouri
Pfizer Investigational Site	Completed
Springfield, Missouri, United States, 65804
United States, New York
Pfizer Investigational Site	Completed
Buffalo, New York, United States, 14222
United States, North Carolina
Pfizer Investigational Site	Recruiting
Durham, North Carolina, United States, 27710
United States, Texas
Pfizer Investigational Site	Recruiting
Houston, Texas, United States, 77030
Pfizer Investigational Site	Recruiting
San Antonio, Texas, United States, 78258
France
Pfizer Investigational Site	Not yet recruiting
Bron cedex, France, 69677
Korea, Republic of
Pfizer Investigational Site	Recruiting
Seoul, Korea, Republic of, 120-752
Mexico
Pfizer Investigational Site	Not yet recruiting
Mexico, DF, Mexico, 04530
Pfizer Investigational Site	Not yet recruiting
Mexico, DF, Mexico, 06720
Pfizer Investigational Site	Active, not recruiting
Guadalajara, Jalisco, Mexico, 44280

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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:	January 5, 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 February 09, 2012