Clinical trial NCT00448916: Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsies, Partial
Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 54
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AE).
timeFrame: 12 Months
Secondary outcomes:
measure: 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.
timeFrame: Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
measure: 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.
timeFrame: Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up
measure: Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).
timeFrame: Visit 1 to 12 Months
measure: Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).
timeFrame: Visit 1 to 12 Months
measure: Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).
timeFrame: Visit 1 to 12 Months
measure: Derived Body Mass Index Data (BMI) at Month 12/Early Termination.
timeFrame: Month 12/Early Termination
measure: 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.
timeFrame: Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up
measure: Height at Month 12/Early Termination.
timeFrame: Month 12/Early Termination
measure: Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
timeFrame: Week 1 to 12 Months
measure: Number of Participants With Hematotolgical Abnormalities.
timeFrame: 12 Months
measure: Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).
timeFrame: 12 Months
measure: Number of Participants With Abnormalities in Endocrine Panel (Hormones).
timeFrame: 12 Months
measure: Number of Participants With Abnormalities in Creatine Kinase.
timeFrame: 12 Months
measure: Seizure Frequency.
timeFrame: 28 Days
measure: Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
timeFrame: 12 Months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Department of Neurology
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Jonesboro
country: United States
facility: The Children's Clinica of Jonesboro, P.A
state: Arkansas
city: Little Rock
country: United States
facility: Clinical Study Centers, L. L. C.
state: Arkansas
city: San Francisco
country: United States
facility: UCSF Neurology Clinic
state: California
city: Gulf Breeze
country: United States
facility: Child Neurology Center of Northwest Florida
state: Florida
city: Tampa
country: United States
facility: The Office of Sergio J Jacinto, MD
state: Florida
city: Tampa
country: United States
facility: Pediatric Epilepsy & Neurology Specialists
state: Florida
city: Springfield
country: United States
facility: St. John's Clinic
state: Missouri
city: Springfield
country: United States
facility: St. John's Hospital
state: Missouri
city: Buffalo
country: United States
facility: Women and Children's Hospital of Buffalo
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: Baylor College of Medicine - Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine Severance Hospital / Department of Pediatric Neurology
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: