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NCT00107926 · ClinicalTrials.gov registry record · Phase 3

Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

A Phase 3 study of Bipolar Disorder, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
343
Enrollment target
20
Study locations

NCT00107926 is a Phase 3 study of Bipolar Disorder that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 343 participants, roughly in line with the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target. The trial reports 20 study locations across 11 states.

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The verdict

NCT00107926, a Phase 3 study of Bipolar Disorder, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
343 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Licarbazepine

Study Locations (20)

Other

  • Novartis Investigational Site - Vienna
  • Novartis investigator site - Greater Sudbury
  • Novartis Investigational Site - Kelowna
  • Novartis investigator site - London
  • Novartis investigator site - Montreal
  • Novartis investigator site - Vancouver
  • Novartis investigator site - Verdun
  • Guatemala - Bogotá

Texas

  • Investigational Site - Bellaire
  • Investigational Site - Dallas

Washington

  • Investigational Site - Bellevue
  • Investigational Site - Kirkland

California

  • Investigational Site - La Palma

Kansas

  • Investigational Site - Kansas City

Louisiana

  • Investigational Site - Shreveport

Massachusetts

  • Investigational Site - Somerville

Michigan

  • Investigational Site - Farmington Hills

Trial Details

FieldValue
Enrollment Target 343 participants
Start Date 2004-10
Est. Completion 2007-08
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00107926

The ClinicalTrials.gov registry entry for NCT00107926 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 343 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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

NCT00107926 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Texas, Washington.

Frequently Asked Questions

What is clinical trial NCT00107926 about?

NCT00107926 is a clinical study titled "Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder". The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Admini...

What is the current status of trial NCT00107926?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 343 participants. The study started on 2004-10. Estimated completion is 2007-08.

What conditions does trial NCT00107926 study?

This clinical trial studies the following conditions: Bipolar Disorder.

What interventions are being tested in trial NCT00107926?

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

Who is sponsoring clinical trial NCT00107926?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00107926 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.