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NCT00437281 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

A Phase 1 study of Epilepsies, Partial, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target
18
Study locations

NCT00437281: Completed Phase 1 study of Epilepsies, Partial, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

NCT00437281 is a Phase 1 study of Epilepsies, Partial that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 65 participants, above the 56-participant average among 4 other Epilepsies, Partial trials with a reported enrollment target (16% higher). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00437281, a Phase 1 study of Epilepsies, Partial, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target
18
Study locations

Study Summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.

Primary Outcome

Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Tre

Conditions Studied

Epilepsies, Partial

Interventions

  • DRUG Placebo
  • DRUG Pregabalin

Study Locations (18)

Florida

  • Pfizer Investigational Site - Gulf Breeze
  • Pfizer Investigational Site - Pensacola
  • Pfizer Investigational Site - Tampa
  • Pfizer Investigational Site - Tampa

Alabama

  • Pfizer Investigational Site - Mobile
  • Pfizer Investigational Site - Mobile

Arkansas

  • Pfizer Investigational Site - Jonesboro
  • Pfizer Investigational Site - Little Rock

Texas

  • Pfizer Investigational Site - Houston
  • Pfizer Investigational Site - San Antonio

Arizona

  • Pfizer Investigational Site - Phoenix

California

  • Pfizer Investigational Site - San Francisco

Missouri

  • Pfizer Investigational Site - Springfield

New York

  • Pfizer Investigational Site - Buffalo

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2007-04
Est. Completion 2012-11
Phase Phase 1
Pfizer's Upjohn has merged with Mylan to form Viatris

158 total trials

What the finished NCT00437281 record still lists

NCT00437281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, above the 56-participant average among 4 other Epilepsies, Partial trials with a reported enrollment target (16% higher).

The record links to 1 condition, with Epilepsies, Partial appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00437281 lists 18 locations in 12 states (Florida, Alabama, Arkansas).

Frequently Asked Questions

What is clinical trial NCT00437281 about?

NCT00437281 is a clinical study titled "Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures". The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.

What is the current status of trial NCT00437281?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2007-04. Estimated completion is 2012-11.

What conditions does trial NCT00437281 study?

This clinical trial studies the following conditions: Epilepsies, Partial.

What interventions are being tested in trial NCT00437281?

The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG).

Who is sponsoring clinical trial NCT00437281?

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 NCT00437281 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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Related registry views

Source: ClinicalTrials.gov NCT00437281, the US trial registry maintained by the National Library of Medicine. NCT00437281 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.