A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
Public ClinicalTrials.gov record NCT01389596. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01389596
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 295 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 27, 2011 (Actual)
- Primary completion
- Aug 10, 2016 (Actual)
- Completion
- Aug 10, 2016 (Actual)
- Last update posted
- Jan 20, 2021
2011 – 2016
United States locations
- U.S. sites
- 20
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Neurosciences | Tucson | Arizona | 85718 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children´s Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Axcess Medical Research | Loxahatchee Groves | Florida | 33470 | — |
| Laszlo J. Mate, M.D., P.A. | North Palm Beach | Florida | 33408 | — |
| Pediatric Neurology, P.A. | Orlando | Florida | 32819 | — |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | — |
| Center for Clinical and Translational Science | Lexington | Kentucky | 40536 | — |
| Kentucky Neuroscience Institute | Lexington | Kentucky | 40536 | — |
| University of Kentucky Hospital Epilepsy Monitoring Unit | Lexington | Kentucky | 40536 | — |
| University of Kentucky Hospital Pharmacy, UK Chandler Hosptial | Lexington | Kentucky | 40536 | — |
| Kosair Charities Pediatric Clinical | Louisville | Kentucky | 40202 | — |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | — |
| University of Louisville Physicians | Louisville | Kentucky | 40202 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| Duke Children's Hospital and Health Center | Durham | North Carolina | 27710 | — |
| Duke Clinical Research Unit | Durham | North Carolina | 27710 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Road Runner Research, Ltd. | San Antonio | Texas | 78258 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 66 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01389596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 20, 2021 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01389596 live on ClinicalTrials.gov.