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Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
NCT00448916 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Pregabalin
Study Locations (18)
Florida
- Child Neurology Center of Northwest Florida — Gulf Breeze
- The Office of Sergio J Jacinto, MD — Tampa
- Pediatric Epilepsy & Neurology Specialists — Tampa
Texas
- Baylor College of Medicine - Texas Children's Hospital — Houston
- Texas Children's Hospital — Houston
- Road Runner Research, Ltd. — San Antonio
Alabama
- University of South Alabama — Mobile
- University of South Alabama Department of Neurology — Mobile
Arkansas
- The Children's Clinica of Jonesboro, P.A — Jonesboro
- Clinical Study Centers, L. L. C. — Little Rock
Missouri
- St. John's Clinic — Springfield
- St. John's Hospital — Springfield
Arizona
- Phoenix Children's Hospital — Phoenix
California
- UCSF Neurology Clinic — San Francisco
New York
- Women and Children's Hospital of Buffalo — Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2007-05 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00448916
The ClinicalTrials.gov registry entry for NCT00448916 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 27 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Epilepsies, Partial appearing as the primary indexed condition, and to 1 intervention — of which Pregabalin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00448916 reports 18 study locations spanning 11 distinct geographic areas — top geographies include Florida, Texas, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00448916 about?
NCT00448916 is a clinical study titled "Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures". 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.
What is the current status of trial NCT00448916?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2007-05. Estimated completion is 2013-10.
What conditions does trial NCT00448916 study?
This clinical trial studies the following conditions: Epilepsies, Partial. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00448916?
The interventions under investigation include: Pregabalin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00448916?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 27 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00448916 being conducted?
This trial has 18 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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