Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00448916
First received: March 15, 2007
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.


Condition Intervention Phase
Epilepsies, Partial
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Month Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses 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, which will be evaluated at every visit throughout the 12 month study period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physical and neurologic exams, vital signs, growth parameters, ECGs, laboratory tests, and seizure frequency, all of which will be evaluated throughout the 12 month study period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: May 2007
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin
Orally-administered 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
  • Completion of study A0081074

Exclusion Criteria:

  • Primary generalized seizures
  • Progressive CNS pathology
  • Failure to tolerate pregabalin in study A0081074
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448916

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
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
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: NCT00448916     History of Changes
Other Study ID Numbers: A0081075
Study First Received: March 15, 2007
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability

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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014