Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
NCT01389596 · View on ClinicalTrials.gov ↗
Study Summary
Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.
Conditions Studied
Interventions
- DRUG Pregabalin add-on therapy
Study Locations (20)
Kentucky
- Center for Clinical and Translational Science — Lexington
- Kentucky Neuroscience Institute — Lexington
- University of Kentucky Hospital Epilepsy Monitoring Unit — Lexington
- University of Kentucky Hospital Pharmacy, UK Chandler Hosptial — Lexington
- Kosair Charities Pediatric Clinical — Louisville
- Kosair Children's Hospital — Louisville
- University of Louisville Physicians — Louisville
Florida
- Axcess Medical Research — Loxahatchee Groves
- Laszlo J. Mate, M.D., P.A. — North Palm Beach
- Pediatric Neurology, P.A. — Orlando
- Tallahassee Neurological Clinic — Tallahassee
California
- Children's Hospital Los Angeles — Los Angeles
- Children´s Hospital Los Angeles — Los Angeles
North Carolina
- Duke Children's Hospital and Health Center — Durham
- Duke Clinical Research Unit — Durham
Arizona
- Center for Neurosciences — Tucson
Arkansas
- Arkansas Children's Hospital — Little Rock
New Jersey
- Saint Peter's University Hospital — New Brunswick
Ohio
- Akron Children's Hospital — Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2011-09-27 |
| Est. Completion | 2016-08-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01389596
The ClinicalTrials.gov registry entry for NCT01389596 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 295 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 Epilepsy, Partial Seizures appearing as the primary indexed condition, and to 1 intervention — of which Pregabalin add-on therapy 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: NCT01389596 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Kentucky, Florida, California. 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 NCT01389596 about?
NCT01389596 is a clinical study titled "A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years". Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subje...
What is the current status of trial NCT01389596?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 295 participants. The study started on 2011-09-27. Estimated completion is 2016-08-10.
What conditions does trial NCT01389596 study?
This clinical trial studies the following conditions: Epilepsy, Partial Seizures. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01389596?
The interventions under investigation include: Pregabalin add-on therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01389596?
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 NCT01389596 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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