Bifeprunox Extension to Extension Study in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00861497
Recruitment Status : Terminated (The study stopped after been paused (the patients were switched in the meantime))
First Posted : March 13, 2009
Last Update Posted : September 16, 2013
Solvay Pharmaceuticals
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
The purpose of this study is to provide access to bifeprunox for patients, who have completed previous studies with bifeprunox, and require continued treatment with bifeprunox, other treatment not being adequate. A further purpose is to investigate the safety and side-effects of bifeprunox during long-term treatment.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Bifeprunox Phase 3

Detailed Description:
This is a non-controlled, open-label, flexible-dose, international multi-centre extension study. The patient population consists of male and female patients with schizophrenia, who have completed open-label bifeprunox studies 10206 or 10265, and require continued treatment with bifeprunox, other treatments not being feasible as judged by the investigator.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Safety Study of Bifeprunox Investigating Flexible Doses of 20, 30, or 40mg/Day in Patients With Schizophrenia Who Have Completed Studies 10206 or 10265
Study Start Date : January 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bifeprunox Drug: Bifeprunox
Flexible dosage: 20, 30, or 40 mg/day

Primary Outcome Measures :
  1. Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS) [ Time Frame: Assessments every 4 to 8 weeks ]

Secondary Outcome Measures :
  1. CGI-S [ Time Frame: Assessments every 4 to 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients, suffering from schizophrenia, having completed studies 10206 or 10265
  • Otherwise healthy
  • Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women using adequate contraception
  • The patient must be in need of treatment with bifeprunox (that is, the switch to another compound is not feasible)

Exclusion Criteria:

  • Current Axis I primary psychiatric diagnosis other than schizophrenia
  • Significant risk of suicide and/or violent behaviour
  • Other psychiatric, neurological or behavioural disorders that may interfere with study conduct
  • Substance or alcohol abuse, current cannabis dependence
  • Clinically significant physical illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00861497

Brescia, Italy, 25123
Sponsors and Collaborators
H. Lundbeck A/S
Solvay Pharmaceuticals
Study Director: Email contact via H. Lundbeck A/S

Responsible Party: H. Lundbeck A/S Identifier: NCT00861497     History of Changes
Other Study ID Numbers: 11051
2005-000497-50 ( EudraCT Number )
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013

Keywords provided by H. Lundbeck A/S:
Safety study

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders