An Open-label Extension Study to Evaluate the Safety and Tolerability 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 750- 2000 mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00228059

Enrollment

132

Registered

2005-09-28

Start date

2005-01-31

Completion date

2007-07-31

Last updated

2017-02-23

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

Conditions

Bipolar I Disorder

Keywords

Bipolar disorder, manic episode/treatment/licarbazepine

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.

Detailed description

A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder

Interventions

DRUGLicarbazepine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. written informed consent provided prior to participation in the extension study 2. successful completion of study CLIC477D2301 3. willingness and ability to comply with all study requirements

Exclusion criteria

1. premature discontinuation from study CLIC477D2301 2. failure to comply with the study CLIC477D2301 protocol

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

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