An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.

Novartis

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder

Treatments: Drug: Licarbazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00228059

CLIC477D2301E1

Details and patient eligibility

About

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.

Full 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

Enrollment: 132 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)