Bifeprunox Extension to Extension Study in Patients With Schizophrenia

This study has been terminated.
(The study stopped after been paused (the patients were switched in the meantime))
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00861497
First received: March 12, 2009
Last updated: September 13, 2013
Last verified: September 2013
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Study Completion Date: July 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bifeprunox 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

Locations
Italy
IT001
Brescia, Italy, 25123
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
ClinicalTrials.gov Identifier: NCT00861497     History of Changes
Other Study ID Numbers: 11051, 2005-000497-50
Study First Received: March 12, 2009
Last Updated: September 13, 2013
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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014