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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsies, Partial

Intervention: Pregabalin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Adverse Events (AE).

Secondary outcome:

Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.

Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.

Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).

Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).

Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).

Derived Body Mass Index Data (BMI) at Month 12/Early Termination.

Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.

Height at Month 12/Early Termination.

Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).

Number of Participants With Hematotolgical Abnormalities.

Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).

Number of Participants With Abnormalities in Endocrine Panel (Hormones).

Number of Participants With Abnormalities in Creatine Kinase.

Seizure Frequency.

Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).

Eligibility

Minimum age: 1 Month. Maximum age: 16 Years. Gender(s): Both.

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

Locations and Contacts

Yonsei University College of Medicine Severance Hospital / Department of Pediatric Neurology, Seoul 120-752, Korea, Republic of

University of South Alabama, Mobile, Alabama 36604, United States

University of South Alabama Department of Neurology, Mobile, Alabama 36693, United States

Phoenix Children's Hospital, Phoenix, Arizona 85016, United States

The Children's Clinica of Jonesboro, P.A, Jonesboro, Arkansas 72401, United States

Clinical Study Centers, L. L. C., Little Rock, Arkansas 72205, United States

UCSF Neurology Clinic, San Francisco, California 94143, United States

Child Neurology Center of Northwest Florida, Gulf Breeze, Florida 32561, United States

Pediatric Epilepsy & Neurology Specialists, Tampa, Florida 33609, United States

The Office of Sergio J Jacinto, MD, Tampa, Florida 33603, United States

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco 44280, Mexico

St. John's Clinic, Springfield, Missouri 65804, United States

St. John's Hospital, Springfield, Missouri 65804, United States

Women and Children's Hospital of Buffalo, Buffalo, New York 14222, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Baylor College of Medicine - Texas Children's Hospital, Houston, Texas 77030, United States

Texas Children's Hospital, Houston, Texas 77030, United States

Road Runner Research, Ltd., San Antonio, Texas 78258, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2007
Last updated: November 24, 2014

Page last updated: August 23, 2015

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