A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures
Public ClinicalTrials.gov record NCT01463306. 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 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
Study identification
- NCT ID
- NCT01463306
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Industry
- Enrollment
- 605 participants
Conditions and interventions
Interventions
- Pregabalin Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Month to 66 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
- Feb 20, 2012
- Primary completion
- Aug 21, 2019
- Completion
- Aug 21, 2019
- Last update posted
- Jan 19, 2021
2012 – 2019
United States locations
- U.S. sites
- 21
- U.S. states
- 12
- U.S. cities
- 19
| 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 | — |
| Axcess Medical Research | Loxahatchee Groves | Florida | 33470 | — |
| Laszlo J. Mate, M.D., P.A. | North Palm Beach | Florida | 33408 | — |
| Pediatric Epilepsy Center Of Central Florida | Orlando | Florida | 32819 | — |
| Pediatric Neurology, PA | Orlando | Florida | 32819 | — |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | — |
| Pediatric Epilepsy and Neurology Specialists, PA | Tampa | Florida | 33609 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
| Josephson Wallack Munshower Neurology P.C. | Indianapolis | Indiana | 46237 | — |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | — |
| University of Louisville Physicians | Louisville | Kentucky | 40202 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Ohio Clinical Research Partners, LLC | Canton | Ohio | 44718 | — |
| The children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | — |
| Dallas Pediatric Neurology Associates | Dallas | Texas | 75230 | — |
| Road Runner Research, Ltd. | San Antonio | Texas | 78249 | — |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | — |
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 130 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01463306, 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 19, 2021 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01463306 live on ClinicalTrials.gov.