Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

Novartis181 enrolled

Overview

This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

181

Conditions

Bipolar Disorder

Interventions

licarbazepineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * written informed consent provided prior to participation in the extension study * successful completion of study CLIC477D2303 * cooperation and willingness to comply with all study requirements Exclusion Criteria: * premature discontinuation from study CLIC477D2303 * failure to comply with study CLIC477D2303

Locations (44)

Outcomes

Primary Outcomes

Safety and tolerability of treatment with licarbazepine over 52 weeks.

with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Investigational site

La Palma, California, United States

Novartis Investigational Site

Kansas City, Kansas, United States

Novartis Investigational Site

Shreveport, Louisiana, United States

Novartis Investigational Site

Somerville, Massachusetts, United States

Novartis Investigational Site

Farmington Hills, Michigan, United States

Novartis Investigational Site

Staten Island, New York, United States

Novartis Investigational Site

Madison, Tennessee, United States

Novartis Investigational Site

Bellaire, Texas, United States

Novartis Investigational Site

Dallas, Texas, United States

Novartis Investigational Site

Verdun, Texas, United States

...and 34 more locations