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OpenTrials
Completed

NCT Number: NCT00139594

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigational Site, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Licarbazepine

Drug

Primary outcomes

  1. Safety and tolerability of treatment with licarbazepine over 52 weeks.

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 31, 2005
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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