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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: Completed Phase 2 study of Epilepsy, sponsored by GlaxoSmithKline.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

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
GlaxoSmithKline

1,345 total trials

What the finished NCT00044278 record still lists

NCT00044278 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (79% lower).

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 names 20 study sites across 11 states, led by 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.

Similar trials for Epilepsy

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 NCT00044278's enrollment target sits among peer trials

197 33rd of 160 higher than 128 of 160 other Epilepsy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Epilepsy 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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Source: ClinicalTrials.gov NCT00044278, the US trial registry maintained by the National Library of Medicine. NCT00044278 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.