A 52 week open-label extension study to evaluate the safety and tolerability of licarbazepine 750-2500 mg/d in the treatment of manic episodes of bipolar I disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000687-27-AT

Enrollment

215

Registered

2004-10-15

Start date

2004-11-19

Completion date

Unknown

Last updated

2013-04-22

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

Conditions

Bipolar I disorder, manic and mixed episodes DSM-IV criteria 296.0, 296.4 or 296.6

Interventions

Product Name: Licarbazepine Product Code: LIC477D Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: •successful completion of study CLIC477D2303 •written informed consent provided prior to participation in the extension study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •premature discontinuation from study CLIC477D2303 •failure to comply with the study CLIC477D2303 protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the tolerability and safety of open-label treatment with licarbazepine 750-2500 mg/d over 52 weeks in patients who completed the 6 week double- blind study CLIC477D2303, with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.;Secondary Objective: To monitor the efficacy of open-label treatment with licarbazepine 750-2500 mg/d over 52 weeks.;Primary end point(s): To assess the tolerability and safety of open-label treatment with licarbazepine 750-2500 mg/d over 52 weeks in patients who completed the 6-week double- blind study CLIC477D2302, with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.	—

Measure

Time frame

Main Objective: To assess the tolerability and safety of open-label treatment with licarbazepine 750-2500 mg/d over 52 weeks in patients who completed the 6 week double- blind study CLIC477D2303, with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.;Secondary Objective: To monitor the efficacy of open-label treatment with licarbazepine 750-2500 mg/d over 52 weeks.;Primary end point(s): To assess the tolerability and safety of open-label treatment with licarbazepine 750-2500 mg/d over 52 weeks in patients who completed the 6-week double- blind study CLIC477D2302, with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.

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Countries

Austria, Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026