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NCT00139594 · ClinicalTrials.gov registry record · Phase 4

Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

A Phase 4 study of Bipolar Disorder, sponsored by Novartis.

Completed
Registry status
Phase 4
Development phase
181
Enrollment target
20
Study locations

NCT00139594 is a Phase 4 study of Bipolar Disorder that has completed, run by Novartis. The registered enrollment target is 181 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00139594, a Phase 4 study of Bipolar Disorder, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 4
Development phase
181 participants
Enrollment target
20
Study locations

Study Summary

This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.

Conditions Studied

Interventions

  • DRUG licarbazepine

Study Locations (20)

Other

  • Novartis Investigational Site - Vienna
  • Novartis Investigational Site - Greater Sudbury
  • Novartis Investigational Site - Kelowna
  • Novartis Investigational Site - London
  • Novartis Investigational Site - Montreal
  • Novartis Investigator Site - Vancouver
  • Novartis Investigational Site - Bogotá

Texas

  • Novartis Investigational Site - Bellaire
  • Novartis Investigational Site - Dallas
  • Novartis Investigational Site - Verdun

Washington

  • Novartis Investigational Site - Bellevue
  • Novartis Investigational Site - Kirkland

California

  • Investigational site - La Palma

Kansas

  • Novartis Investigational Site - Kansas City

Louisiana

  • Novartis Investigational Site - Shreveport

Massachusetts

  • Novartis Investigational Site - Somerville

Michigan

  • Novartis Investigational Site - Farmington Hills

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2004-12
Est. Completion 2007-07
Phase Phase 4

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT00139594

The ClinicalTrials.gov registry entry for NCT00139594 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (45% lower). The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

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

NCT00139594 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Texas, Washington.

Frequently Asked Questions

What is clinical trial NCT00139594 about?

NCT00139594 is a clinical study titled "Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder". This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.

What is the current status of trial NCT00139594?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 181 participants. The study started on 2004-12. Estimated completion is 2007-07.

What conditions does trial NCT00139594 study?

This clinical trial studies the following conditions: Bipolar Disorder.

What interventions are being tested in trial NCT00139594?

The interventions under investigation include: licarbazepine (DRUG).

Who is sponsoring clinical trial NCT00139594?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00139594 being conducted?

This trial has 20 study locations across California, Kansas, Louisiana, Massachusetts, Michigan. 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

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.