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NCT01389596 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
A Phase 3 study of Epilepsy, Partial Seizures, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 295
- Enrollment target
- 20
- Study locations
NCT01389596: Completed Phase 3 study of Epilepsy, Partial Seizures, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01389596 is a Phase 3 study of Epilepsy, Partial Seizures that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 295 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01389596, a Phase 3 study of Epilepsy, Partial Seizures, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 295 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the baseline phase\] divided by \[number of days in baseline phase minus {-} number of missing diary days in baseline phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure
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 |
What the finished NCT01389596 record still lists
NCT01389596 is an interventional study that assigns participants to a tested intervention. The registered 295 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 (62% lower).
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.
NCT01389596 names 20 study sites across 9 states, led by Kentucky, Florida, California.
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.
What interventions are being tested in trial NCT01389596?
The interventions under investigation include: Pregabalin add-on therapy (DRUG).
Who is sponsoring clinical trial NCT01389596?
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 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.
Learn More About Clinical Trials
Similar trials for Epilepsy, Partial Seizures
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01389596's enrollment target sits among peer trials
295 1166th of 2000 higher than 835 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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