Status:
TERMINATED
STEPS Trial - Spheramine Safety and Efficacy Study
Lead Sponsor:
Bayer
Collaborating Sponsors:
Titan Pharmaceuticals
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to explore the safety, tolerability and efficacy of Spheramine (cultured human retinal pigment epithelial cells on microcarriers) in Parkinson's Disease patients with advan...
Detailed Description
This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Sc...
Eligibility Criteria
Inclusion
- Advanced Parkinson's disease for at least 5 years
- Good response to L-dopa
- Age 30 to 70 years
- Optimum oral therapy
Exclusion
- Tremor only
- Dementia
- Very severe dyskinesia
- Previous brain surgery including deep brain stimulation
- Malignant disease
Key Trial Info
Start Date :
January 8 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2012
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00206687
Start Date
January 8 2003
End Date
May 14 2012
Last Update
October 31 2024
Active Locations (15)
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1
Birmingham, Alabama, United States, 35233
2
Los Angeles, California, United States, 90095
3
Tampa, Florida, United States, 33606
4
Atlanta, Georgia, United States, 30329