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

NCT00448916 | Completed Phase 3 Results

• 2 other identifiers: A00810752010-020731-39
• Study Type: interventional
• Target: 54
• Locations: 3 countries
• Sites: 18

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.

Conditions

Epilepsies, Partial

Keywords

Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AE).

  An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.

  12 Months

Secondary Outcomes (15)

• 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.

  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.

  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).

  Visit 1 to 12 Months

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

  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).

  Visit 1 to 12 Months

Study Arms (1)

Pregabalin

EXPERIMENTAL

Orally-administered pregabalin

Drug: Pregabalin

Interventions

Pregabalin DRUG

Orally-administered pregabalin

Pregabalin

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Partial onset seizures, incompletely controlled on 1-3 medications
• At least 1 seizure per 28 days, on average
• Completion of study A0081074

You may not qualify if:

• Primary generalized seizures
• Progressive CNS pathology
• Failure to tolerate pregabalin in study A0081074

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (18)

University of South Alabama

Mobile, Alabama, 36604, United States

Location

University of South Alabama Department of Neurology

Mobile, Alabama, 36693, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

The Children's Clinica of Jonesboro, P.A

Jonesboro, Arkansas, 72401, United States

Location

Clinical Study Centers, L. L. C.

Little Rock, Arkansas, 72205, United States

Location

UCSF Neurology Clinic

San Francisco, California, 94143, United States

Location

Child Neurology Center of Northwest Florida

Gulf Breeze, Florida, 32561, United States

Location

The Office of Sergio J Jacinto, MD

Tampa, Florida, 33603, United States

Location

Pediatric Epilepsy & Neurology Specialists

Tampa, Florida, 33609, United States

Location

St. John's Clinic

Springfield, Missouri, 65804, United States

Location

St. John's Hospital

Springfield, Missouri, 65804, United States

Location

Women and Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Baylor College of Medicine - Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Road Runner Research, Ltd.

San Antonio, Texas, 78258, United States

Location

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

Yonsei University College of Medicine Severance Hospital / Department of Pediatric Neurology

Seoul, 120-752, South Korea

Location

Related Links

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

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: May 1, 2007
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 25, 2021
• Results First Posted: December 2, 2014

Record last verified: 2014-11

Locations

US (16); ME (1); KR (1)