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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139594

Enrollment

181

Registered

2005-08-31

Start date

2004-12-31

Completion date

2007-07-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar disorder, manic episode/treatment/licarbazepine

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.

Interventions

DRUGlicarbazepine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Austria, Canada, Colombia, Czechia, Germany, Guatemala, Peru, Russia, Slovakia, South Africa, Ukraine, United States, Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026