STEPS Trial - Spheramine Safety and Efficacy Study
| Status: | Terminated |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | January 2003 |
| End Date: | May 2012 |
Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease
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.
(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.
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.
Inclusion Criteria:
- Advanced Parkinson's disease for at least 5 years
- Good response to L-dopa
- Age 30 to 70 years
- Optimum oral therapy
Exclusion Criteria:
- Tremor only
- Dementia
- Very severe dyskinesia
- Previous brain surgery including deep brain stimulation
- Malignant disease
We found this trial at
11
sites
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