Status:
TERMINATED
Bifeprunox Extension to Extension Study in Patients With Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 bei...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00861497
Start Date
January 1 2006
End Date
July 1 2009
Last Update
September 16 2013
Active Locations (1)
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1
IT001
Brescia, Italy, 25123