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COMPLETED Phase 3

An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder

NCT00579982 · View on ClinicalTrials.gov ↗

Study Summary

To determine the convenience and satisfaction of new orally disintegrating tablet formulation (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study in participants with a mood disorder, who reported difficulty or discomfort in swallowing the currently marketed IR compressed tablet formulation of lamotrigine and who had a person (such as a spouse, partner, companion, aid, nurse, caregiver, etc) willing to complete a Companion/Caregiver Question. Subjects were switched from the currently marketed lamotrigine IR formulation to a matching dose of lamotrigine IR orally disintegrating tablet (ODT) for 3 weeks to determine convenience and satisfaction.

Conditions Studied

Interventions

  • DRUG Lamotrigine

Study Locations (18)

Florida

  • GSK Investigational Site — Jacksonville
  • GSK Investigational Site — Orange City
  • GSK Investigational Site — Winter Park

Texas

  • GSK Investigational Site — Arlington
  • GSK Investigational Site — Houston
  • GSK Investigational Site — Houston

California

  • GSK Investigational Site — San Diego
  • GSK Investigational Site — Santa Ana

Ohio

  • GSK Investigational Site — Cincinnati
  • GSK Investigational Site — Cleveland

Georgia

  • GSK Investigational Site — Marietta

Illinois

  • GSK Investigational Site — Fairview Heights

Minnesota

  • GSK Investigational Site — Minneapolis

Missouri

  • GSK Investigational Site — Saint Charles

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2008-01
Est. Completion 2008-02
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00579982

The ClinicalTrials.gov registry entry for NCT00579982 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Mood Disorders appearing as the primary indexed condition, and to 1 intervention — of which Lamotrigine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00579982 reports 18 study locations spanning 12 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00579982 about?

NCT00579982 is a clinical study titled "An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder". To determine the convenience and satisfaction of new orally disintegrating tablet formulation (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study in participants with a mood disorder, who reported difficulty or discomfort in swallowing the currently marketed ...

What is the current status of trial NCT00579982?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2008-01. Estimated completion is 2008-02.

What conditions does trial NCT00579982 study?

This clinical trial studies the following conditions: Mood Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00579982?

The interventions under investigation include: Lamotrigine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00579982?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00579982 being conducted?

This trial has 18 study locations across California, Florida, Georgia, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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