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 advanced disease who have insufficient symptom control by optimum oral medication. Patients are randomized to receive Spheramine injections into both hemispheres or a sham surgical procedure in a ratio of 1:1. A three month pretreatment period must be completed prior to surgery. Time to endpoint is 24 months.
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 Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
71
Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.
Unnamed facility
Birmingham, Alabama, United States
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Los Angeles, California, United States
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Tampa, Florida, United States
Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
Time frame: 12 months post surgery
Change in total UPDRS in ON and OFF at 12 months post surgery
Time frame: 12 months post surgery
Change in UPDRS Part III in ON at 12 months post surgery
Time frame: 12 months post surgery
Amount of L-dopa reduction at 12 months post surgery
Time frame: 12 months post surgery
Activities of Daily Living subscore of the UPDRS at 12 months post surgery
Time frame: 12 months post surgery
Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery
Time frame: 12 months post surgery
Percent time spent in ON and OFF at 12 months post surgery
Time frame: 12 months post surgery
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Unnamed facility
Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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Philadelphia, Pennsylvania, United States
Unnamed facility
Houston, Texas, United States
...and 5 more locations