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| Descriptive Information Fields | |||||
| Brief Title † | STEPS Trial - Spheramine Safety and Efficacy Study | ||||
| Official Title † | Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease | ||||
| 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 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. |
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| 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 Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Change in total UPDRS in ON and OFF at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ] Change in UPDRS Part III in ON at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ] Amount of L-dopa reduction at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ] Activities of Daily Living subscore of the UPDRS at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ] Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ] Percent time spent in ON and OFF at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ] |
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| Condition † | Parkinson Disease | ||||
| Intervention † | Procedure: Spheramine Procedure: Placebo |
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| MEDLINE PMIDs | |||||
| Links | This study is the same study protocol as NCT00185406, with different locations.  Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 68 | ||||
| Start Date † | January 2003 | ||||
| Completion Date | June 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Germany, Spain | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00206687 | ||||
| Organization ID | 91039 | ||||
| Secondary IDs †† | 305405 | ||||
| Study Sponsor † | Bayer | ||||
| Collaborators †† | Titan Pharmaceuticals | ||||
| Investigators † |
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| Information Provided By | Bayer | ||||
| Verification Date | October 2008 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | October 27, 2008 | ||||
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