Bifeprunox Extension to Extension Study in Patients With Schizophrenia - Full Text View

Sponsors and Collaborators:	H. Lundbeck A/S Solvay Pharmaceuticals
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00861497

Purpose

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	Intervention	Phase
Schizophrenia	Drug: Bifeprunox	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Bifeprunox Bifeprunox mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
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

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

CGI-S [ Time Frame: Assessments every 4 to 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	11
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2009
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Bifeprunox Flexible dosage: 20, 30, or 40 mg/day

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861497

Sponsors and Collaborators

H. Lundbeck A/S

Solvay Pharmaceuticals

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

No publications provided

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	11051, EudraCT 2005-000497-50
Study First Received:	March 12, 2009
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00861497 History of Changes
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by H. Lundbeck A/S:

Open-label
Flexible-dose
Extension
Safety study

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009