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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00139594
• Collaborator: (none)
• Enrollment: 181
• Locations: 44
• Arm: 1
• Duration (Months): 30.9
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: licarbazepine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 181 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2004
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: licarbazepine	Drug: licarbazepine

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of treatment with licarbazepine over 52 weeks. []

2. with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational site	La Palma	California	United States	20623
2	Novartis Investigational Site	Kansas City	Kansas	United States
3	Novartis Investigational Site	Shreveport	Louisiana	United States
4	Novartis Investigational Site	Somerville	Massachusetts	United States
5	Novartis Investigational Site	Farmington Hills	Michigan	United States
6	Novartis Investigational Site	Staten Island	New York	United States
7	Novartis Investigational Site	Madison	Tennessee	United States
8	Novartis Investigational Site	Bellaire	Texas	United States
9	Novartis Investigational Site	Dallas	Texas	United States
10	Novartis Investigational Site	Verdun	Texas	United States
11	Novartis Investigational Site	Bellevue	Washington	United States
12	Novartis Investigational Site	Kirkland	Washington	United States
13	Novartis Investigational site	West Allis	Wisconsin	United States
14	Novartis Investigational Site	Vienna		Austria
15	Novartis Investigational Site	Kelowna		Canada
16	Novartis Investigational Site	London		Canada
17	Novartis Investigational Site	Montreal		Canada
18	Novartis Investigational Site	Sudbury		Canada
19	Novartis Investigator Site	Vancouver		Canada
20	Novartis Investigational Site	Bogota		Colombia
21	Novartis Investigational Site	Medellin		Colombia
22	Novartis Investigational Site	Pareira		Colombia
23	Novartis Investigational Site	Brno		Czech Republic
24	Novartis Investigational Site	Hradec Kralove		Czech Republic
25	Novartis Investigational Site	Prague		Czech Republic
26	Novartis Investigational Site	Berlin		Germany
27	Novartis Investigational Site	Bochum		Germany
28	Novartis Investigational Site	Dresden		Germany
29	Novartis Investigational Site	Ingolstadt		Germany
30	Novartis Investigational Site	Mannheim		Germany
31	Novartis Investigational Site	Wurzburg		Germany
32	Novartis Investigational Site	Guatemala City		Guatemala
33	Novartis Investigational Site	Lima		Peru
34	Novartis Investigational Site	Moscow		Russian Federation
35	Novartis Investigational Site	Yaroslavl		Russian Federation
36	Novartis Investigational Site	Bojnice		Slovakia
37	Novartis Investigational Site	Michalovce		Slovakia
38	Novartis Investigational Site	Durban		South Africa
39	Novartis Investigational Site	Dnepropetrovsk		Ukraine
40	Novartis Investigational Site	Kiev		Ukraine
41	Novartis Investigational Site	Lugansk		Ukraine
42	Novartis Investigational Site	Odessa		Ukraine
43	Novartis Investigational Site	Simferopol		Ukraine
44	Novartis Investigational Site	Caracas		Venezuela

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00139594
• Other Study ID Numbers: CLIC477D2303E1
• First Posted: Aug 31, 2005
• Last Update Posted: Mar 28, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Novartis: Bipolar disorder, manic episode/treatment/licarbazepine
• Additional relevant MeSH terms: Mania; Disease; Bipolar Disorder

Study Results

No Results Posted as of Mar 28, 2017