A Phase 2 interventional study of Spheramine (BAY86-5280) and Placebo in Parkinson Disease, sponsored by Bayer. Terminated at 15 sites in 3 countries. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 71 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.
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Exclusion Criteria:
Biological: Spheramine (BAY86-5280)
Procedure: Placebo
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.
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
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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