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An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder

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Novartis

Status and phase

Completed
Phase 3

Conditions

Bipolar I Disorder

Treatments

Drug: Licarbazepine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00238485
CLIC477D2302E1

Details and patient eligibility

About

This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.

Enrollment

251 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • written informed consent provided prior to participation in the extension study.
  • successful completion of the study CLIC477D2302
  • willingness and ability to comply with all study requirements

Exclusion criteria

  • premature discontinuation from the study CLIC477D2302
  • failure to comply with the study CLIC477D2302 protocol

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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