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NCT00448916 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
A Phase 3 study of Epilepsies, Partial, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
- 18
- Study locations
NCT00448916: Completed Phase 3 study of Epilepsies, Partial, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00448916 is a Phase 3 study of Epilepsies, Partial that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 54 participants, roughly in line with the 59-participant average among 4 other Epilepsies, Partial trials with a reported enrollment target. The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00448916, a Phase 3 study of Epilepsies, Partial, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
- 18
- Study locations
Study Summary
The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.
Primary Outcome
An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; re
Conditions Studied
Interventions
- DRUG Pregabalin
Study Locations (18)
Florida
- Child Neurology Center of Northwest Florida - Gulf Breeze
- The Office of Sergio J Jacinto, MD - Tampa
- Pediatric Epilepsy & Neurology Specialists - Tampa
Texas
- Baylor College of Medicine - Texas Children's Hospital - Houston
- Texas Children's Hospital - Houston
- Road Runner Research, Ltd. - San Antonio
Alabama
- University of South Alabama - Mobile
- University of South Alabama Department of Neurology - Mobile
Arkansas
- The Children's Clinica of Jonesboro, P.A - Jonesboro
- Clinical Study Centers, L. L. C. - Little Rock
Missouri
- St. John's Clinic - Springfield
- St. John's Hospital - Springfield
Arizona
- Phoenix Children's Hospital - Phoenix
California
- UCSF Neurology Clinic - San Francisco
New York
- Women and Children's Hospital of Buffalo - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2007-05 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT00448916 record still lists
NCT00448916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, roughly in line with the 59-participant average among 4 other Epilepsies, Partial trials with a reported enrollment target.
The record links to 1 condition, with Epilepsies, Partial appearing as the primary indexed condition, and to 1 intervention - of which Pregabalin is the first listed.
NCT00448916 lists 18 locations in 11 states (Florida, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT00448916 about?
NCT00448916 is a clinical study titled "Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures". The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.
What is the current status of trial NCT00448916?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2007-05. Estimated completion is 2013-10.
What conditions does trial NCT00448916 study?
This clinical trial studies the following conditions: Epilepsies, Partial.
What interventions are being tested in trial NCT00448916?
The interventions under investigation include: Pregabalin (DRUG).
Who is sponsoring clinical trial NCT00448916?
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 NCT00448916 being conducted?
This trial has 18 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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