search
Back to results

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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
licarbazepine
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, manic episode/treatment/licarbazepine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: written informed consent provided prior to participation in the extension study successful completion of study CLIC477D2303 cooperation and willingness to comply with all study requirements Exclusion Criteria: premature discontinuation from study CLIC477D2303 failure to comply with study CLIC477D2303

Sites / Locations

  • Investigational site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigator Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

licarbazepine

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of treatment with licarbazepine over 52 weeks.
with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2005
Last Updated
March 24, 2017
Sponsor
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT00139594
Brief Title
Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
Official Title
A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar disorder, manic episode/treatment/licarbazepine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
licarbazepine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
licarbazepine
Primary Outcome Measure Information:
Title
Safety and tolerability of treatment with licarbazepine over 52 weeks.
Title
with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: written informed consent provided prior to participation in the extension study successful completion of study CLIC477D2303 cooperation and willingness to comply with all study requirements Exclusion Criteria: premature discontinuation from study CLIC477D2303 failure to comply with study CLIC477D2303
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
La Palma
State/Province
California
ZIP/Postal Code
20623
Country
United States
Facility Name
Novartis Investigational Site
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Novartis Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Novartis Investigational Site
City
Somerville
State/Province
Massachusetts
Country
United States
Facility Name
Novartis Investigational Site
City
Farmington Hills
State/Province
Michigan
Country
United States
Facility Name
Novartis Investigational Site
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Novartis Investigational Site
City
Madison
State/Province
Tennessee
Country
United States
Facility Name
Novartis Investigational Site
City
Bellaire
State/Province
Texas
Country
United States
Facility Name
Novartis Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Novartis Investigational Site
City
Verdun
State/Province
Texas
Country
United States
Facility Name
Novartis Investigational Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Novartis Investigational Site
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Novartis Investigational site
City
West Allis
State/Province
Wisconsin
Country
United States
Facility Name
Novartis Investigational Site
City
Vienna
Country
Austria
Facility Name
Novartis Investigational Site
City
Kelowna
Country
Canada
Facility Name
Novartis Investigational Site
City
London
Country
Canada
Facility Name
Novartis Investigational Site
City
Montreal
Country
Canada
Facility Name
Novartis Investigational Site
City
Sudbury
Country
Canada
Facility Name
Novartis Investigator Site
City
Vancouver
Country
Canada
Facility Name
Novartis Investigational Site
City
Bogota
Country
Colombia
Facility Name
Novartis Investigational Site
City
Medellin
Country
Colombia
Facility Name
Novartis Investigational Site
City
Pareira
Country
Colombia
Facility Name
Novartis Investigational Site
City
Brno
Country
Czech Republic
Facility Name
Novartis Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Novartis Investigational Site
City
Prague
Country
Czech Republic
Facility Name
Novartis Investigational Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigational Site
City
Bochum
Country
Germany
Facility Name
Novartis Investigational Site
City
Dresden
Country
Germany
Facility Name
Novartis Investigational Site
City
Ingolstadt
Country
Germany
Facility Name
Novartis Investigational Site
City
Mannheim
Country
Germany
Facility Name
Novartis Investigational Site
City
Wurzburg
Country
Germany
Facility Name
Novartis Investigational Site
City
Guatemala City
Country
Guatemala
Facility Name
Novartis Investigational Site
City
Lima
Country
Peru
Facility Name
Novartis Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Bojnice
Country
Slovakia
Facility Name
Novartis Investigational Site
City
Michalovce
Country
Slovakia
Facility Name
Novartis Investigational Site
City
Durban
Country
South Africa
Facility Name
Novartis Investigational Site
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Kiev
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Lugansk
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Odessa
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Simferopol
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs