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NCT01463306 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Epilepsy, Partial Seizures and Epilepsy, Primary Generalized Tonic-Clonic Seizures, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 605
- Enrollment target
- 20
- Study locations
NCT01463306: Completed Phase 3 study of Epilepsy, Partial Seizures and Epilepsy, Primary Generalized Tonic-Clonic Seizures, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01463306 is a Phase 3 study of Epilepsy, Partial Seizures and Epilepsy, Primary Generalized Tonic-Clonic Seizures that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 605 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01463306, a Phase 3 study of Epilepsy, Partial Seizures and Epilepsy, Primary Generalized Tonic-Clonic Seizures, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 605 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study A0081106 is a 12-month open-label study to evaluate the long term 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. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.
Primary Outcome
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days
Conditions Studied
Interventions
- DRUG Pregabalin
Study Locations (20)
Florida
- Axcess Medical Research - Loxahatchee Groves
- Laszlo J. Mate, M.D., P.A. - North Palm Beach
- Pediatric Epilepsy Center Of Central Florida - Orlando
- Pediatric Neurology, PA - Orlando
- Tallahassee Neurological Clinic - Tallahassee
- Pediatric Epilepsy and Neurology Specialists, PA - Tampa
Kentucky
- Kosair Children's Hospital - Louisville
- University of Louisville Physicians - Louisville
Ohio
- Akron Children's Hospital - Akron
- Ohio Clinical Research Partners, LLC - Canton
Pennsylvania
- The children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center - Pittsburgh
Texas
- Dallas Pediatric Neurology Associates - Dallas
- Road Runner Research, Ltd. - San Antonio
Arizona
- Center for Neurosciences - Tucson
Arkansas
- Arkansas Children's Hospital - Little Rock
California
- Children's Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 605 participants |
| Start Date | 2012-02-21 |
| Est. Completion | 2019-08-22 |
| Phase | Phase 3 |
What the finished NCT01463306 record still lists
NCT01463306 is an interventional study that assigns participants to a tested intervention. The registered 605 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 2 conditions, with Epilepsy, Partial Seizures appearing as the primary indexed condition, and to 1 intervention - of which Pregabalin is the first listed.
NCT01463306 names 20 study sites across 11 states, led by Florida, Kentucky, Ohio.
Frequently Asked Questions
What is clinical trial NCT01463306 about?
NCT01463306 is a clinical study titled "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". Study A0081106 is a 12-month open-label study to evaluate the long term 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 sei...
What is the current status of trial NCT01463306?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 605 participants. The study started on 2012-02-21. Estimated completion is 2019-08-22.
What conditions does trial NCT01463306 study?
This clinical trial studies the following conditions: Epilepsy, Partial Seizures, Epilepsy, Primary Generalized Tonic-Clonic Seizures.
What interventions are being tested in trial NCT01463306?
The interventions under investigation include: Pregabalin (DRUG).
Who is sponsoring clinical trial NCT01463306?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01463306 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01463306's enrollment target sits among peer trials
605 607th of 2000 higher than 1,394 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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