A 52-week, opem- label extension study to evaluate the sahety and tolerability of licarbazepine 750-2500 mg/d in the treatment of manic episodes of bipolar I disorder - D2303E1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000687-27-CZ

Enrollment

Unknown

Registered

2006-07-24

Start date

2006-09-20

Completion date

Unknown

Last updated

2023-08-21

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

Interventions

Product Name: Licarbazepine Product Code: LIC477 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Licarbazepine CAS Number: 29331-92-8 Current Sponsor code: LIC477 Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. written informed consent provided prior to participation in the extension study 2. successful completion of study CLIC477D2303 3. cooperation and willingness to comply with all study requirements 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: 1. premature discontinuation from study CLIC477D2303 2. failure to comply with study CLIC477D2303

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of open-label treatment with licarbazepine 750-2000 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 750-2000 mg/d over 52 weeks.;Primary end point(s): To assess long-term safety and tolerability of licarbazepine 750-2000 mg/d in this extension study, adverse events and serious adverse will be recorded. Further assessments will include physical examination, vital signs, laboratory evaluations, and ECGs.	—

Measure

Time frame

Main Objective: To assess the safety and tolerability of open-label treatment with licarbazepine 750-2000 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 750-2000 mg/d over 52 weeks.;Primary end point(s): To assess long-term safety and tolerability of licarbazepine 750-2000 mg/d in this extension study, adverse events and serious adverse will be recorded. Further assessments will include physical examination, vital signs, laboratory evaluations, and ECGs.

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Countries

Austria, Czech Republic, Slovakia

Outcome results

None listed

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