Bifeprunox Extension to Extension Study in Patients With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00861497
• Other study ID #: 11051
• Secondary ID: 2005-000497-50
• Status: Terminated
• Phase: Phase 3
• First received: March 12, 2009
• Last updated: September 13, 2013
• Start date: January 2006
• Est. completion date: July 2009

Study information

• Verified date: September 2013
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Bifeprunox
Flexible dosage: 20, 30, or 40 mg/day

Locations

Country	Name	City	State
Italy	IT001	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Solvay Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS)		Assessments every 4 to 8 weeks	Yes
Secondary	CGI-S		Assessments every 4 to 8 weeks	No