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NCT00044278 · ClinicalTrials.gov registry record · Phase 2

Pediatric Epilepsy Study in Subjects 1-24 Months

A Phase 2 study of Epilepsy, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
197
Enrollment target
20
Study locations

NCT00044278 is a Phase 2 study of Epilepsy that has completed, run by GlaxoSmithKline. The registered enrollment target is 197 participants, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00044278, a Phase 2 study of Epilepsy, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
197 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

Conditions Studied

Epilepsy

Interventions

  • DRUG lamotrigine

Study Locations (20)

Florida

  • GSK Investigational Site - Jacksonville
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Orlando
  • GSK Investigational Site - Tallahassee
  • GSK Investigational Site - Tampa

California

  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Stanford

Arkansas

  • GSK Investigational Site - Jonesboro
  • GSK Investigational Site - Little Rock

Georgia

  • GSK Investigational Site - Atlanta
  • GSK Investigational Site - Augusta

Missouri

  • GSK Investigational Site - Columbia
  • GSK Investigational Site - Kansas City

Alabama

  • GSK Investigational Site - Mobile

Arizona

  • GSK Investigational Site - Tucson

Colorado

  • GSK Investigational Site - Denver

Trial Details

FieldValue
Enrollment Target 197 participants
Start Date 2000-09
Est. Completion 2006-06
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00044278

The ClinicalTrials.gov registry entry for NCT00044278 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 197 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (79% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which lamotrigine is the first listed.

NCT00044278 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00044278 about?

NCT00044278 is a clinical study titled "Pediatric Epilepsy Study in Subjects 1-24 Months". This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's c...

What is the current status of trial NCT00044278?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2000-09. Estimated completion is 2006-06.

What conditions does trial NCT00044278 study?

This clinical trial studies the following conditions: Epilepsy.

What interventions are being tested in trial NCT00044278?

The interventions under investigation include: lamotrigine (DRUG).

Who is sponsoring clinical trial NCT00044278?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00044278 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.