NCT00228059

Brief Summary

This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

September 26, 2005

Last Update Submit

February 21, 2017

Conditions

Bipolar I Disorder

Keywords

Bipolar disorder, manic episode/treatment/licarbazepine

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.

Interventions

LicarbazepineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent provided prior to participation in the extension study
  • successful completion of study CLIC477D2301
  • willingness and ability to comply with all study requirements

You may not qualify if:

  • premature discontinuation from study CLIC477D2301
  • failure to comply with the study CLIC477D2301 protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site

Cerritos, California, United States

Location

Related Links

MeSH Terms

Conditions

Bipolar DisorderMania

Interventions

10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmcuticals

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)