drugset / Trial / NCT00228059

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

NCT00228059 ↗

Phase 3 Completed 132 enrolled Novartis
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-01
Primary completion
2007-07
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Licarbazepine Small molecule 750 mg —
Subject Licarbazepine Small molecule 2000 mg —

Indications